{ "name": "LED face masks on Amazon checked against FDA records", "description": "74 best-selling LED face masks on Amazon, each searched in FDA's 510(k) and Registration & Listing databases, with what each Amazon listing says about FDA.", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "source_page": "https://verifiedbeautydata.com/research/led-face-mask-fda-check/", "publisher": "Verified Beauty Data", "sample": "Best-selling LED face masks on amazon.com by Amazon sales rank (Beauty & Personal Care), drawn 2026-10-04; neck, chest and bundle listings removed.", "fda_records_matched": "2026-10-09", "listings_and_fda_rechecked": "2026-10-13", "fda_full_record_recheck": { "date": "2026-10-13", "510k_records": 443, "summary_pdfs_read": 397, "listing_records": 962, "product_codes": [ "OHS", "OLP", "ILY" ], "pulled": "2026-10-13", "note": "46 ILY clearances from before 2001 have no PDF on FDA's site.", "masks_corrected": 15, "rule": "Tied = an FDA record links the brand to the device: a 510(k) or FDA device listing names the brand or mask (and any model the listing shows is in that filing or listing), or the brand gives a K number and its model is in that filing or listing. A model number that matches a factory's filing is not enough on its own." }, "findings": { "FDA filing tied to this mask": 22, "Factory filing, brand not named": 24, "Brand has a clearance, not for this model": 8, "Says FDA, no record found": 4, "No FDA claim, no record found": 16 }, "listings_live": 71, "listings_saying_fda": 24, "listings_saying_fda_by_finding": { "FDA filing tied to this mask": 9, "Factory filing, brand not named": 11, "Brand has a clearance, not for this model": 0, "Says FDA, no record found": 4, "No FDA claim, no record found": 0 }, "limits": [ "\"No record found\" means we searched and found none. It does not prove no filing exists.", "A filing in a factory's name counts as tied only when an FDA record names the brand or mask, or the brand gives that K number and its model is in the filing. A model number alone that matches a factory's filing is \"Factory filing, brand not named.\"", "FDA device listings are filed by companies; FDA does not check each brand name in them.", "FDA clearance is about safety and similarity to an older device. It is not a test of results.", "Amazon listings and prices change. Prices are Amazon's on the date shown per row." ], "masks": [ { "rank": 1, "asin": "B0DYG4Q6PL", "brand": "Shark", "name": "CryoGlow", "tie": "tied", "live": true, "says_fda": true, "claim_where": "bullets", "claim_quote": "Clinically tested on 119 participants by an independent third party & FDA-cleared for results you can see", "claim_url": "https://verifiedbeautydata.com/go/b0dyg4q6pl-1gag5ya/", "k_number": "K242796", "filing_device": "CryoGlow (FW3XXXX)", "filed_by": "Sharkninja Operating, LLC", "decided": "2024-11-27", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242796.pdf", "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "FDA filing K242796 ('CryoGlow (FW3XXXX)', filed by Sharkninja Operating, LLC) names this brand or mask.", "seller": "Amazon.com", "price": 339.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0dsgjcs47-0zqrvnu/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0dsgjcs47-0zqrvnu/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 2, "asin": "B0FLDP8Y5W", "brand": "INIA", "name": "Red Light Therapy Mask for Face", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K243040", "filing_device": "LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)", "filed_by": "Shenzhen Siken 3D Technology Development Co., Ltd.", "decided": "2024-12-20", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243040", "note": "Amazon part number IN-FM002 is one of nine models in Shenzhen Siken's filing K243040. No FDA record names INIA, and the listing makes no FDA claim.", "fda_rechecked": false, "corrected": true, "finding_before": "No FDA claim, no record found", "evidence": "K243040 device name lists IN-FM002 among nine models, Shenzhen Siken; Amazon part number IN-FM002. No record names INIA.", "reason": "Amazon part number IN-FM002 is one of nine models in Shenzhen Siken's filing K243040. No FDA record names INIA, and the listing makes no FDA claim.", "seller": "INIA Official US", "price": 76.48, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0fldp8y5w-00kc5qg/", "fda_finding": "Factory filing, brand not named" }, { "rank": 3, "asin": "B0FNWRJQFX", "brand": "INIA", "name": "GLOW 4D", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K243040", "filing_device": "LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)", "filed_by": "Shenzhen Siken 3D Technology Development Co., Ltd.", "decided": "2024-12-20", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243040.pdf", "note": "The listing's model (SKB-1918P) is in filing K243040 by Shenzhen Siken 3D Technology Development Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing's model (SKB-1918P) is in filing K243040 by Shenzhen Siken 3D Technology Development Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "seller": "INIA Official US", "price": 179.98, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0fnwrjqfx-00cn5fz/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0fnwrjqfx-00cn5fz/", "fda_finding": "Factory filing, brand not named" }, { "rank": 4, "asin": "B0DHRW819R", "brand": "CurrentBody", "name": "LED Light Therapy Mask Series 2", "tie": "tied", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K250966", "filing_device": "CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)", "filed_by": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decided": "2025-06-25", "cleared_for": "wrinkles", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250966.pdf", "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "FDA filing K250966 ('CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)', filed by Shenzhen Kaiyan Medical Equipment Co., Ltd.) names this brand or mask.", "seller": "The Beauty Tech Group Ltd", "price": 449.95, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": false, "listing_url": null, "fda_finding": "FDA filing tied to this mask" }, { "rank": 5, "asin": "B0DZ6SLJQ3", "brand": "wavytalk", "name": "Red Light Therapy Mask for Face", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K243555", "filing_device": "LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)", "filed_by": "Shenzhen Eyco Technology Co., Ltd.", "decided": "2025-02-05", "cleared_for": "both (acne primary, wrinkles secondary)", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243555.pdf", "note": "The listing's model (E106A) is in filing K243555 by Shenzhen Eyco Technology Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing's model (E106A) is in filing K243555 by Shenzhen Eyco Technology Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "seller": "wavytalk US", "price": 109.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0dz6sljq3-0itapge/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0dz6sljq3-0itapge/", "fda_finding": "Factory filing, brand not named" }, { "rank": 6, "asin": "B0D7N2KWLH", "brand": "iRestore", "name": "LED Face Mask", "tie": "other", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K260688", "filing_device": "Sculpt LED Belt", "filed_by": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decided": "2026-05-04", "cleared_for": null, "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260688", "note": "iRestore's own clearances are hair-growth devices; a factory listing names an 'iRESTORE Sculpt LED Belt' (K260688). No record covers the face mask.", "fda_rechecked": true, "corrected": true, "finding_before": "No FDA claim, no record found", "evidence": "iRestore's own 510(k)s (Freedom Laser Therapy: K151662, K183417, K213094, K222081) are all product code OAP, hair growth. openFDA registrationlisting K260688 (Shenzhen Kaiyan): 'iRESTORE Sculpt LED Belt'. No record covers the face mask.", "reason": "iRestore's own clearances are hair-growth devices; a factory listing names an 'iRESTORE Sculpt LED Belt' (K260688). No record covers the face mask.", "seller": "iRESTORE -", "price": 379, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0d7n2kwlh-1vaxpg2/", "fda_finding": "Brand has a clearance, not for this model" }, { "rank": 7, "asin": "B0H1WKB9WR", "brand": "MICEYLIVE", "name": "Red Light Therapy for Face", "tie": "possible", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "MICEYLIVE Red Light Therapy for Face, FDA-Cleared Blue Light Mask for Acne", "claim_url": "https://verifiedbeautydata.com/go/b0h1wkb9wr-02nbdd0/", "k_number": "K243555", "filing_device": "LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)", "filed_by": "Shenzhen Eyco Technology Co., Ltd.", "decided": "2025-02-05", "cleared_for": "both (acne primary, wrinkles secondary)", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243555", "note": "Amazon part number E106A is a model in Shenzhen Eyco's filing K243555. No FDA record names MICEYLIVE, and the listing gives no K number.", "fda_rechecked": true, "corrected": true, "finding_before": "Says FDA, no record found", "evidence": "Amazon part number E106A; K243555 device name lists E106A (Shenzhen Eyco). No record names MICEYLIVE/MALIONLAN; listing photos show no K or model number.", "reason": "Amazon part number E106A is a model in Shenzhen Eyco's filing K243555. No FDA record names MICEYLIVE, and the listing gives no K number.", "seller": "MALIONLAN", "price": 89.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h1wkb9wr-02nbdd0/", "fda_finding": "Factory filing, brand not named" }, { "rank": 8, "asin": "B0CZ8NZ97F", "brand": "HIME SAMA", "name": "LED Face Mask", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "CL-Beauty", "price": 360, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0cz8nz97f-18cdum6/", "fda_finding": "No FDA claim, no record found" }, { "rank": 9, "asin": "B0H4L65XG4", "brand": "Aimilove", "name": "Red Light Therapy Mask for Face", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K243423", "filing_device": "LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)", "filed_by": "Shenzhen Rainbow Technology Co., Ltd.", "decided": "2025-01-28", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243423.pdf", "note": "The listing's model (RB-008) is in filing K243423 by Shenzhen Rainbow Technology Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing's model (RB-008) is in filing K243423 by Shenzhen Rainbow Technology Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "seller": "Yumustar", "price": 79.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0h4l65xg4-0l27h0h/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h4l65xg4-0l27h0h/", "fda_finding": "Factory filing, brand not named" }, { "rank": 10, "asin": "B0FJS8ZQWS", "brand": "RENPHO", "name": "Rejuven", "tie": "tied", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "RENPHO Red Light Therapy Mask for Face, 324 LEDs, 850nm NIR, FDA-Cleared", "claim_url": "https://verifiedbeautydata.com/go/b0fjs8zqws-1i2u2ad/", "k_number": "K243555", "filing_device": "LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)", "filed_by": "Shenzhen Eyco Technology Co., Ltd.", "decided": "2025-02-05", "cleared_for": "both (acne primary, wrinkles secondary)", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243555", "note": "FDA device listing under K243555 reads 'LED light therapy mask (renpho rejuven, KFYVFS, model: E100B)'; the Amazon model is E100B and the mask is printed 'RENPHO REJUVEN'.", "fda_rechecked": false, "corrected": true, "finding_before": "Likely filing, not tied to this mask", "evidence": "openFDA registrationlisting K243555, Shenzhen Eyco: proprietary_name 'LED light therapy mask (renpho rejuven, KFYVFS, model: E100B)'. Amazon model E100B; listing photo shows mask printed 'RENPHO REJUVEN'.", "reason": "FDA device listing under K243555 reads 'LED light therapy mask (renpho rejuven, KFYVFS, model: E100B)'; the Amazon model is E100B and the mask is printed 'RENPHO REJUVEN'.", "seller": "Smartindex", "price": 169.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0fjs8zqws-1i2u2ad/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0fjs8zqws-1i2u2ad/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 11, "asin": "B0H1D72ZGB", "brand": "Aesthifae", "name": "Red Light Therapy Mask for Face and Neck", "tie": "other", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K261407", "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261407", "note": "Sold by the iFae store. FDA's device listing names iFae LED masks under K261407, but that filing lists other model numbers, so we could not confirm this one.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "Sold by the iFae store. FDA's device listing names iFae LED masks under K261407, but that filing lists other model numbers, so we could not confirm this one.", "seller": "iFae Store", "price": 85.49, "buyable": false, "amazon_checked": "2026-10-25", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h1d72zgb-05hpcfa/", "fda_finding": "Brand has a clearance, not for this model" }, { "rank": 12, "asin": "B0F8QJL13N", "brand": "Kelyoo", "name": "Red Light Therapy for Face Mask", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K213056", "filing_device": "LED Facial Mask", "filed_by": "Shenzhen Osto Technology Company Limited", "decided": "2022-07-07", "cleared_for": "both (acne; periorbital/full-face wrinkles)", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213056.pdf", "note": "The listing's model (AST-805) is in filing K213056 by Shenzhen Osto Technology Company Limited, but no FDA record names the brand and the listing gives no K number.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing's model (AST-805) is in filing K213056 by Shenzhen Osto Technology Company Limited, but no FDA record names the brand and the listing gives no K number.", "seller": "Znxtop", "price": 69.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0f8qjl13n-118gawu/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0f8qjl13n-118gawu/", "fda_finding": "Factory filing, brand not named" }, { "rank": 13, "asin": "B01MDK70V9", "brand": "NEWKEY", "name": "4D LED Red Light Therapy Mask for Face", "tie": "tied", "live": false, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K230351", "filing_device": "LED Facial Mask", "filed_by": "Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.", "decided": "2023-05-05", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230351.pdf", "note": "FDA filing K230351 ('LED Facial Mask', filed by Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.) names this brand or mask.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "FDA filing K230351 (Shenzhen Sungpo) lists model NEWKEY-01, the brand's own code for this mask.", "seller": "NEWKEY", "price": 159.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": false, "listing_url": null, "fda_finding": "FDA filing tied to this mask" }, { "rank": 14, "asin": "B08NCRHNW9", "brand": "Dr Dennis Gross", "name": "DRx SpectraLite FaceWare Pro", "tie": "claim", "live": true, "says_fda": true, "claim_where": "bullets", "claim_quote": "Dermatologist-developed and FDA cleared", "claim_url": "https://verifiedbeautydata.com/go/b08ncrhnw9-0cpcfuw/", "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": "The brand says FDA cleared but gives no K number. We found no filing that names Dr. Dennis Gross or this mask.", "fda_rechecked": true, "corrected": false, "finding_before": null, "evidence": null, "reason": "The brand says FDA cleared but gives no K number. We found no filing that names Dr. Dennis Gross or this mask.", "seller": "Dr. Dennis Gross Skincare, LLC", "price": 455, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b08ncrhnw9-0cpcfuw/", "fda_finding": "Says FDA, no record found" }, { "rank": 15, "asin": "B0CM4GBPP7", "brand": "LifePro", "name": "RevitaGlow", "tie": "tied", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K233114", "filing_device": "LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)", "filed_by": "Shenzhen Idea Light Limited", "decided": "2024-01-12", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233114.pdf", "note": "FDA filing K233114 ('LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)', filed by Shenzhen Idea Light Limited) names this brand or mask.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "FDA filing K233114 (Shenzhen Idea Light) lists models LP-RVTGLWP-WHT and LP-RVTGLW-WHT, LifePro's own codes for the RevitaGlow (LP-RVTGLW).", "seller": "Amazon.com", "price": 199.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0cm4gbpp7-0v8i8f3/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0cm4gbpp7-0v8i8f3/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 16, "asin": "B0H2PR356X", "brand": "Andalusite", "name": "Red Light Therapy for Face", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "VISDOCK", "price": 70.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h2pr356x-029ugzf/", "fda_finding": "No FDA claim, no record found" }, { "rank": 17, "asin": "B0GXGMJ6NM", "brand": "IFAE", "name": "Red Light Therapy Mask for Face and Neck", "tie": "other", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K261407", "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261407", "note": "FDA's device listing names iFae LED masks under K261407, but that filing lists other model numbers, so we could not confirm this one.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "FDA's device listing names iFae LED masks under K261407, but that filing lists other model numbers, so we could not confirm this one.", "seller": "inSkinBeauty", "price": 149.98, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gxgmj6nm-0dvjxsr/", "fda_finding": "Brand has a clearance, not for this model" }, { "rank": 18, "asin": "B0FKD3826X", "brand": "Therabody", "name": "TheraFace Mask Glo", "tie": "tied", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": "https://verifiedbeautydata.com/go/b0fkd3826x-0c54ht3/", "k_number": "K230293", "filing_device": "TheraFace Mask", "filed_by": "Therabody, Inc.", "decided": "2023-06-09", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230293.pdf", "note": "FDA's device listing names the TheraFace Mask Glo under K230293, Therabody's own clearance.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "FDA's device listing names the TheraFace Mask Glo under K230293, Therabody's own clearance.", "seller": "TheraGun", "price": 379.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0fkd3826x-0c54ht3/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 19, "asin": "B0DT14FRPG", "brand": "Ulike", "name": "ReGlow", "tie": "tied", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K243492", "filing_device": "Ulike Reglow Light Therapy Device (UM10)", "filed_by": "Shenzhen Ulike Smart Electronics Co., Ltd.", "decided": "2025-01-10", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243492.pdf", "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "FDA filing K243492 is Ulike's own: 'Ulike Reglow Light Therapy Device (UM10)', the Amazon model.", "seller": "Ulike Official US", "price": 259, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0dt14frpg-0z6bz9x/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0dt14frpg-0z6bz9x/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 20, "asin": "B0F181GKGZ", "brand": "INIA", "name": "Red Light Therapy Mask for Face", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K243040", "filing_device": "LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)", "filed_by": "Shenzhen Siken 3D Technology Development Co., Ltd.", "decided": "2024-12-20", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243040", "note": "Amazon part number IN-FM002 is one of nine models in Shenzhen Siken's filing K243040. No FDA record names INIA, and the listing makes no FDA claim.", "fda_rechecked": false, "corrected": true, "finding_before": "No FDA claim, no record found", "evidence": "K243040 device name lists IN-FM002 among nine models, Shenzhen Siken; Amazon part number IN-FM002. No record names INIA.", "reason": "Amazon part number IN-FM002 is one of nine models in Shenzhen Siken's filing K243040. No FDA record names INIA, and the listing makes no FDA claim.", "seller": "INIA Official US", "price": 159.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0f181gkgz-109ufbk/", "fda_finding": "Factory filing, brand not named" }, { "rank": 21, "asin": "B0GWMJ4HRC", "brand": "pedete", "name": "Red Light Therapy Mask for Face", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "Pedete Beauty", "price": 139.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gwmj4hrc-1xzbd6v/", "fda_finding": "No FDA claim, no record found" }, { "rank": 22, "asin": "B0GYYZM69D", "brand": "XSSNVV", "name": "Red Light Therapy Mask for Face", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "XSSNVV GLOW", "price": 89.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gyyzm69d-0g7vduw/", "fda_finding": "No FDA claim, no record found" }, { "rank": 23, "asin": "B0H1GNQQSF", "brand": "RENPHO", "name": "Red Light Therapy Mask for Face", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K243040", "filing_device": "LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)", "filed_by": "Shenzhen Siken 3D Technology Development Co., Ltd.", "decided": "2024-12-20", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243040", "note": "Amazon part number SKB-2418 is a model in Shenzhen Siken's filing K243040; no FDA record ties RENPHO to it (RENPHO is listed for a different mask, E100B).", "fda_rechecked": false, "corrected": true, "finding_before": "No FDA claim, no record found", "evidence": "Amazon part number SKB-2418; K243040 device name lists SKB-2418 (Shenzhen Siken).", "reason": "Amazon part number SKB-2418 is a model in Shenzhen Siken's filing K243040; no FDA record ties RENPHO to it (RENPHO is listed for a different mask, E100B).", "seller": "Smartindex", "price": 139.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h1gnqqsf-1nhogq8/", "fda_finding": "Factory filing, brand not named" }, { "rank": 24, "asin": "B0H4K9S83M", "brand": "Qynera", "name": "Red Light Therapy for Face & Neck", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K251667", "filing_device": "LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)", "filed_by": "Shenzhen Liyoutong Technology Co., Ltd.", "decided": "2025-08-07", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251667.pdf", "note": "The listing's model (M09) is in filing K251667 by Shenzhen Liyoutong Technology Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing's model (M09) is in filing K251667 by Shenzhen Liyoutong Technology Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "seller": "Yangtou", "price": 119.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0h4k9s83m-1c88j56/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h4k9s83m-1c88j56/", "fda_finding": "Factory filing, brand not named" }, { "rank": 25, "asin": "B0815RDG2N", "brand": "Aphrona", "name": "Moonlight LED Facial Mask Skin Care Mask", "tie": "tied", "live": false, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K192295", "filing_device": "Aphrona LED facial mask", "filed_by": "Beijing ADSS Development", "decided": null, "cleared_for": "acne", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192295", "note": "Listed with FDA as \"Aphrona LED facial mask\" under K192295 by Beijing ADSS Development.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "Listed with FDA as \"Aphrona LED facial mask\" under K192295 by Beijing ADSS Development.", "seller": "Daman USA", "price": 169.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": false, "listing_url": null, "fda_finding": "FDA filing tied to this mask" }, { "rank": 26, "asin": "B0GQ85DDJF", "brand": "PRAVOLE", "name": "Red Light Therapy Mask for Face", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K251667", "filing_device": "LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)", "filed_by": "Shenzhen Liyoutong Technology Co., Ltd.", "decided": "2025-08-07", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251667.pdf", "note": "The listing's model (M08) is in filing K251667 by Shenzhen Liyoutong Technology Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing's model (M08) is in filing K251667 by Shenzhen Liyoutong Technology Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "seller": "King GLOW", "price": 79.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0gq85ddjf-16wu6ye/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gq85ddjf-16wu6ye/", "fda_finding": "Factory filing, brand not named" }, { "rank": 27, "asin": "B0GGT5W6MW", "brand": "Vital Vibes", "name": "Red Light Therapy LED Face Mask + Collagen", "tie": "possible", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "Vital Vibes FDA Cleared Red Light Therapy LED Face Mask + Collagen Serum", "claim_url": "https://verifiedbeautydata.com/go/b0ggt5w6mw-1jeeb8t/", "k_number": "K243555", "filing_device": "LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)", "filed_by": "Shenzhen Eyco Technology Co., Ltd.", "decided": "2025-02-05", "cleared_for": "both (acne primary, wrinkles secondary)", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243555", "note": "Amazon part number 'VV-RLT001 (E106A)'; E106A is a model in Shenzhen Eyco's filing K243555. No FDA record names Vital Vibes, and it gives no K number.", "fda_rechecked": true, "corrected": true, "finding_before": "Says FDA, no record found", "evidence": "Amazon part number 'VV-RLT001 (E106A)'; K243555 device name lists E106A (Shenzhen Eyco). No record names Vital Vibes.", "reason": "Amazon part number 'VV-RLT001 (E106A)'; E106A is a model in Shenzhen Eyco's filing K243555. No FDA record names Vital Vibes, and it gives no K number.", "seller": "VITAL VIBES", "price": 134.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0ggt5w6mw-1jeeb8t/", "fda_finding": "Factory filing, brand not named" }, { "rank": 28, "asin": "B0GZTFRSYH", "brand": "INTEO", "name": "Red Light Therapy Mask for Face", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K252189", "filing_device": "LED Light Therapy Mask (2311, 2344, 2457, 2458)", "filed_by": "Dongguan Yanxi Technology Co., Ltd.", "decided": "2025-09-12", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252189", "note": "Amazon model 2311 is a model in Dongguan Yanxi's filing K252189 ('2311, 2344, 2457, 2458'). A bare number, so a weak match.", "fda_rechecked": false, "corrected": true, "finding_before": "No FDA claim, no record found", "evidence": "Amazon model 2311; K252189 'LED Light Therapy Mask Model(s): 2311, 2344, 2457, 2458' (Dongguan Yanxi). Numeric code: weak.", "reason": "Amazon model 2311 is a model in Dongguan Yanxi's filing K252189 ('2311, 2344, 2457, 2458'). A bare number, so a weak match.", "seller": "INTEO-Smart", "price": 149.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gztfrsyh-1xtcyzk/", "fda_finding": "Factory filing, brand not named" }, { "rank": 29, "asin": "B0GZNXFPHF", "brand": "Lunacyo", "name": "Red Light Therapy Mask Face", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "Lyntop", "price": 99.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gznxfphf-10h5yyq/", "fda_finding": "No FDA claim, no record found" }, { "rank": 30, "asin": "B0GJCSJTWX", "brand": "SHMHE", "name": "LED Face Mask", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "SHMHE", "price": 26.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gjcsjtwx-00jp90z/", "fda_finding": "No FDA claim, no record found" }, { "rank": 31, "asin": "B0H6BV9PB5", "brand": "BONLIBRO", "name": "Red Light Therapy Mask for Face", "tie": "possible", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "BONLIBRO FDA Cleared Red Light Therapy Mask for Face, 850nm NIR, 320 LEDs", "claim_url": null, "k_number": "K241857", "filing_device": "LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)", "filed_by": "Dongguan Boyuan Intelligent Technology Co.,Ltd", "decided": "2024-10-11", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241857.pdf", "note": "The listing gives K241857, cleared for Dongguan Boyuan (the maker Amazon names) for models KFB290, KFB291, KFB265 and KFB293. The listing shows no model number (the box reads 'REGOLW 2'), so we could not confirm it is one of them.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing gives K241857, cleared for Dongguan Boyuan (the maker Amazon names) for models KFB290, KFB291, KFB265 and KFB293. The listing shows no model number (the box reads 'REGOLW 2'), so we could not confirm it is one of them.", "seller": "BONLIBRO Health", "price": 69.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": false, "listing_url": null, "fda_finding": "Factory filing, brand not named" }, { "rank": 32, "asin": "B0GVNWWRLS", "brand": "KNNKNN", "name": "Red Light Therapy Mask for Face", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "KNNKNN", "price": 69.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gvnwwrls-1glz07j/", "fda_finding": "No FDA claim, no record found" }, { "rank": 33, "asin": "B0HF4J6WCZ", "brand": "ONLUKY", "name": "Red Light Therapy for Face", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "ONLUKY Store", "price": 109.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0hf4j6wcz-0bwrb7n/", "fda_finding": "No FDA claim, no record found" }, { "rank": 34, "asin": "B0GYDCNDBQ", "brand": "Gleelar", "name": "3-in-1 LED Face Mask", "tie": "possible", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "Gleelar 3-in-1 LED Face Mask, FDA-Cleared Red Light Therapy Mask for Face", "claim_url": "https://verifiedbeautydata.com/go/b0gydcndbq-1gjyipr/", "k_number": "K250880", "filing_device": "LED LIGHT MASK (A093)", "filed_by": "Foshan Guangyu Weilai Medical Equipment Co., Ltd.", "decided": "2025-06-20", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250880", "note": "Amazon part number A093 matches 'LED LIGHT MASK (A093)' in Foshan Guangyu Weilai's filing K250880 and FDA listing. No FDA record names Gleelar, and it gives no K number.", "fda_rechecked": true, "corrected": true, "finding_before": "Says FDA, no record found", "evidence": "Amazon part number A093; K250880 device name 'LED LIGHT MASK (A093)' and FDA listing of the same name (Foshan Guangyu Weilai). No record names Gleelar.", "reason": "Amazon part number A093 matches 'LED LIGHT MASK (A093)' in Foshan Guangyu Weilai's filing K250880 and FDA listing. No FDA record names Gleelar, and it gives no K number.", "seller": "Woot", "price": 107.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gydcndbq-1gjyipr/", "fda_finding": "Factory filing, brand not named" }, { "rank": 35, "asin": "B0H46247JN", "brand": "Weltallina", "name": "Red Light Therapy Mask for Face", "tie": "tied", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "FDA-Cleared Red Light Therapy Mask for Face, 4 Light Modes with 850nm NIR for Anti-Aging, Wrinkle Reduction&Acne", "claim_url": "https://verifiedbeautydata.com/go/b0h46247jn-0zkq0d0/", "k_number": "K243978", "filing_device": "LED Facial Mask", "filed_by": "Shenzhen Sunsred Technology Co.,Ltd", "decided": "2025-06-20", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243978.pdf", "note": "FDA filing K243978 ('LED Facial Mask', filed by Shenzhen Sunsred Technology Co.,Ltd) names this brand or mask.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing gives K243978 (Shenzhen Sunsred, the maker Amazon names), and its model SR-M4 is in that filing.", "seller": "Weltallina", "price": 53.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0h46247jn-0zkq0d0/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h46247jn-0zkq0d0/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 36, "asin": "B0GSGRCFFZ", "brand": "TOYHIS", "name": "LED Face Mask Light Therapy", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "TOYHIS US", "price": 29.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gsgrcffz-0ah2q93/", "fda_finding": "No FDA claim, no record found" }, { "rank": 37, "asin": "B07R4S5ZT4", "brand": "AAOCARE", "name": "Hydraskincare Red Light Therapy for Face", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "YANSU 2000 INC", "price": 219.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b07r4s5zt4-1ldiv4i/", "fda_finding": "No FDA claim, no record found" }, { "rank": 38, "asin": "B0H1B3J3G2", "brand": "NOMADARA", "name": "3D Cordless Red Light Therapy Mask for Face", "tie": "tied", "live": true, "says_fda": true, "claim_where": "bullets", "claim_quote": "FDA 510(k) Cleared – K253712", "claim_url": "https://verifiedbeautydata.com/go/b0h1b3j3g2-094tc9b/", "k_number": "K253712", "filing_device": "LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)", "filed_by": "Shenzhen Rainbow Technology Co., Ltd.", "decided": "2026-01-23", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253712", "note": "The listing gives K253712, and its model RB-071 is named in that filing (Shenzhen Rainbow). Caveat: Amazon names a different company (Shenzhen Xinlong) as maker.", "fda_rechecked": false, "corrected": true, "finding_before": "Likely filing, not tied to this mask", "evidence": "Amazon bullets: 'FDA 510(k) Cleared - K253712'. K253712 device name 'LED Light Therapy Mask (RB-051, RB-061, RB-071, ...)'; Amazon model RB-071. Amazon names Shenzhen Xinlong as maker; the filer is Shenzhen Rainbow.", "reason": "The listing gives K253712, and its model RB-071 is named in that filing (Shenzhen Rainbow). Caveat: Amazon names a different company (Shenzhen Xinlong) as maker.", "seller": "Iceberg Toys", "price": 179.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h1b3j3g2-094tc9b/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 39, "asin": "B0HB4DH1KG", "brand": "LuxRenew", "name": "4D Contour-Fit LED Light Therapy Mask for Face", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "MusesNew", "price": 99.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0hb4dh1kg-1szmv3u/", "fda_finding": "No FDA claim, no record found" }, { "rank": 40, "asin": "B0HFMXBC4H", "brand": "EVFOFO", "name": "Wireless Red Light Therapy Mask for Face", "tie": "possible", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "FDA Wireless Red Light Therapy Mask for Face: 850nm NIR, Acne & Wrinkles", "claim_url": "https://verifiedbeautydata.com/go/b0hfmxbc4h-1vx8t0x/", "k_number": "K253054", "filing_device": "LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)", "filed_by": "Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.", "decided": "2025-12-19", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253054.pdf", "note": "The listing's model (M19-2) is in filing K253054 by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing's model (M19-2) is in filing K253054 by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "seller": "ZHANHZ Store", "price": 89.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0hfmxbc4h-1vx8t0x/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0hfmxbc4h-1vx8t0x/", "fda_finding": "Factory filing, brand not named" }, { "rank": 41, "asin": "B0G8T8FGX2", "brand": "Jorking", "name": "Red Light Therapy for Face", "tie": "tied", "live": false, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K253712", "filing_device": "LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)", "filed_by": "Shenzhen Rainbow Technology Co., Ltd.", "decided": "2026-01-23", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253712.pdf", "note": "FDA filing K253712 ('LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)', filed by Shenzhen Rainbow Technology Co., Ltd.) names this brand or mask.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing gave K253712 (Shenzhen Rainbow), and its model RB-061 is in that filing (read October 9; the listing is no longer on Amazon).", "seller": "Moonlit future store", "price": 99.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": false, "listing_url": null, "fda_finding": "FDA filing tied to this mask" }, { "rank": 42, "asin": "B0CDX275Q2", "brand": "CurrentBody", "name": "LED Light Therapy Mask Series 1", "tie": "tied", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K221946", "filing_device": "LED Light Therapy Mask (model: MK66R-B)", "filed_by": "Light Tree Ventures Europe B.V.", "decided": "2022-11-22", "cleared_for": "wrinkles", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221946.pdf", "note": "FDA's device listing names Currentbody under K221946, filed for CurrentBody's parent company; the Series 2 filing cites K221946 as its earlier mask.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "FDA's device listing names Currentbody under K221946, filed for CurrentBody's parent company; the Series 2 filing cites K221946 as its earlier mask.", "seller": "LioSeller", "price": 249, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0cdx275q2-068wjg7/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 43, "asin": "B0H25ZMJ6M", "brand": "SecretSky", "name": "Red Light Therapy Mask for Face", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "Woot", "price": 99.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h25zmj6m-1saplba/", "fda_finding": "No FDA claim, no record found" }, { "rank": 44, "asin": "B0FHGVG4HV", "brand": "biuufish", "name": "Red Light Therapy Mask for Face and Neck", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "YHDZ-US", "price": 139.98, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": false, "listing_url": null, "fda_finding": "No FDA claim, no record found" }, { "rank": 45, "asin": "B0CR17G9HZ", "brand": "GYH", "name": "8-Color LED Face Mask Light Therapy", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "GYH OFFICIAL STORE", "price": 360, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0cr17g9hz-0x5fkr2/", "fda_finding": "No FDA claim, no record found" }, { "rank": 46, "asin": "B0H3L81NMF", "brand": "Aesthifae", "name": "Red Light Therapy for Face", "tie": "other", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K261407", "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261407", "note": "Sold by the iFae store. FDA's device listing names iFae LED masks under K261407, but that filing lists other model numbers, so we could not confirm this one.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "Sold by the iFae store. FDA's device listing names iFae LED masks under K261407, but that filing lists other model numbers, so we could not confirm this one.", "seller": "iFae Store", "price": 79.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h3l81nmf-09uiu7k/", "fda_finding": "Brand has a clearance, not for this model" }, { "rank": 47, "asin": "B0CPY3NKWB", "brand": "MEGELIN", "name": "Led Red Light Therapy Face & Neck Mask", "tie": "tied", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K252264", "filing_device": "MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)", "filed_by": "Shenzhen Zhenxing Ruitong Technology Co., Ltd.", "decided": "2025-10-17", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252264.pdf", "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "FDA filing K252264 ('MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)', filed by Shenzhen Zhenxing Ruitong Technology Co., Ltd.) names this brand or mask.", "seller": "Megelin Official US", "price": 362.7, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0cpy3nkwb-02f6z04/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0cpy3nkwb-02f6z04/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 48, "asin": "B0GS2LKCZY", "brand": "Qure", "name": "Q-Rejuvalight Pro", "tie": "tied", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "Qure LED Light Therapy Mask for Face - FDA Cleared for Wrinkles & Acne Treatment with 3 Modes, 5 Facial Areas & 5 Lights: Red, Deep-Red, Blue, Amber & Infrared, 3-Min Daily, Eye-Protection, Smart App", "claim_url": "https://verifiedbeautydata.com/go/b0gs2lkczy-0pnl6ue/", "k_number": "K230042", "filing_device": "Q-Rejuvalight Pro Facewear (Model: P19-0023)", "filed_by": "Light Tree Ventures Europe B.V.", "decided": "2023-04-28", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230042.pdf", "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "FDA filing K230042 ('Q-Rejuvalight Pro Facewear (Model: P19-0023)', filed by Light Tree Ventures Europe B.V.) names this brand or mask.", "seller": "Qure Skincare", "price": 283, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gs2lkczy-0pnl6ue/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 49, "asin": "B0CR3PBQ25", "brand": "MEGELIN", "name": "7 Colors Led Light Therapy Facial Mask", "tie": "other", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K252264", "filing_device": "MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)", "filed_by": "Shenzhen Zhenxing Ruitong Technology Co., Ltd.", "decided": "2025-10-17", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252264.pdf", "note": "MEGELIN's clearance covers its JML masks. This 7-color mask is a different model, and the listing makes no FDA claim.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "MEGELIN's clearance covers its JML masks. This 7-color mask is a different model, and the listing makes no FDA claim.", "seller": "Megelin Official US", "price": 239, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0cr3pbq25-05zxf7b/", "fda_finding": "Brand has a clearance, not for this model" }, { "rank": 50, "asin": "B0HF4XV2BP", "brand": "SDKWDH", "name": "Red Light Therapy for Face", "tie": "possible", "live": true, "says_fda": true, "claim_where": "bullets", "claim_quote": "Our FDA Cleared device utilizes professional-grade 630nm red and 850nm infrared light to penet…", "claim_url": "https://verifiedbeautydata.com/go/b0hf4xv2bp-1jxlkc1/", "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": "The listing says FDA cleared. Its model name, M01, appears in three different companies' filings, so we could not tie it to one.", "fda_rechecked": true, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing says FDA cleared. Its model name, M01, appears in three different companies' filings, so we could not tie it to one.", "seller": "ZHANHZ Store", "price": 48.59, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0hf4xv2bp-1jxlkc1/", "fda_finding": "Factory filing, brand not named" }, { "rank": 51, "asin": "B0DQSK8Y52", "brand": "Nanoleaf", "name": "LED Light Therapy Face Mask", "tie": "tied", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "Nanoleaf FDA-Cleared LED Light Therapy Face Mask with 7 Treatment Modes", "claim_url": "https://verifiedbeautydata.com/go/b0dqsk8y52-0y528ls/", "k_number": "K243555", "filing_device": "LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)", "filed_by": "Shenzhen Eyco Technology Co., Ltd.", "decided": "2025-02-05", "cleared_for": "both (acne primary, wrinkles secondary)", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243555", "note": "Nanoleaf's support site says its mask 'Model E49' is covered by K243555; Amazon gives part number '2021081201, E49', which matches an FDA listing under K243555 word for word. Caveat: the 510(k) itself names E49B and E49C, not E49.", "fda_rechecked": true, "corrected": true, "finding_before": "Brand has a clearance, not for this model", "evidence": "support.nanoleaf.me article 41533132708372: 'The Light Therapy Mask labeled \"Model E49\" is covered under FDA 510(k) clearance K243555.' openFDA registrationlisting K243555 (Shenzhen Eyco): 'LED light therapy mask(model: 2021081201, E49)'; Amazon part number '2021081201, E49'. The 510(k) device name lists E49B and E49C.", "reason": "Nanoleaf's support site says its mask 'Model E49' is covered by K243555; Amazon gives part number '2021081201, E49', which matches an FDA listing under K243555 word for word. Caveat: the 510(k) itself names E49B and E49C, not E49.", "seller": "Nanoleaf USA", "price": 169.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0dqsk8y52-0y528ls/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 52, "asin": "B0H4GDDD9N", "brand": "BONLIBRO", "name": "Red Light Therapy Mask for Face", "tie": "tied", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "FDA Cleared Red Light Therapy Mask for Face, Infrared Light Mask 416 LEDs", "claim_url": "https://verifiedbeautydata.com/go/b0h4gddd9n-1a6mbu9/", "k_number": "K253054", "filing_device": "LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)", "filed_by": "Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.", "decided": "2025-12-19", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253054.pdf", "note": "FDA filing K253054 ('LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)', filed by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.) names this brand or mask.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing gives K253054 (Shenzhen Xinlong, the maker Amazon names), and its model M19-6 is in that filing.", "seller": "BONLIBRO Health", "price": 62.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0h4gddd9n-1a6mbu9/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h4gddd9n-1a6mbu9/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 53, "asin": "B0GMY6J9L2", "brand": "AIHEU", "name": "3D Cordless Red Light Therapy Mask for Face", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "Wellness-Mall", "price": 69.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gmy6j9l2-1se4qr1/", "fda_finding": "No FDA claim, no record found" }, { "rank": 54, "asin": "B0GZPSGMZG", "brand": "CHCANYAOYU", "name": "Wireless LED Light Therapy Mask", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K253054", "filing_device": "LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)", "filed_by": "Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.", "decided": "2025-12-19", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253054", "note": "Amazon names Shenzhen Xinlong as maker and part number M19-1, a model in Xinlong's filing K253054.", "fda_rechecked": false, "corrected": true, "finding_before": "No FDA claim, no record found", "evidence": "Amazon maker Shenzhen Xinlong, part number M19-1; K253054 device name lists M19-1.", "reason": "Amazon names Shenzhen Xinlong as maker and part number M19-1, a model in Xinlong's filing K253054.", "seller": "riqigoyo", "price": 69.98, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gzpsgmzg-07ze6ga/", "fda_finding": "Factory filing, brand not named" }, { "rank": 55, "asin": "B08NCGWVPY", "brand": "Omnilux", "name": "Contour Face", "tie": "tied", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": "https://omniluxled.com/products/contour-face", "k_number": "K191629", "filing_device": "Omnilux Contour", "filed_by": "I-SMART Development and The Beauty Tech Group", "decided": null, "cleared_for": "wrinkles", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191629", "note": "Listed with FDA as \"Omnilux Contour\" under K191629 by I-SMART Development and The Beauty Tech Group.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "Listed with FDA as \"Omnilux Contour\" under K191629 by I-SMART Development and The Beauty Tech Group.", "seller": "Posh Gifts Online", "price": 442.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b08ncgwvpy-17yp9xb/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b08ncgwvpy-17yp9xb/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 56, "asin": "B0GJZTTZ3C", "brand": "dreame", "name": "Chrona Photon", "tie": "tied", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": "https://dreame.com.au/products/dreame-chrona-photon-anti-aging-skincare-mask", "k_number": "K253712", "filing_device": "Dreame Chrona Photon Anti-Aging Skincare Mask (RB-053)", "filed_by": "Dreame Trading", "decided": null, "cleared_for": "wrinkles and acne", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253712", "note": "Listed with FDA as \"Dreame Chrona Photon Anti-Aging Skincare Mask (RB-053)\" under K253712 by Dreame Trading.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "Listed with FDA as \"Dreame Chrona Photon Anti-Aging Skincare Mask (RB-053)\" under K253712 by Dreame Trading.", "seller": "Dreame Technology HK Limited", "price": 269.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0gjzttz3c-03ttgzi/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gjzttz3c-03ttgzi/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 57, "asin": "B0FSSMBJ44", "brand": "IFAE", "name": "Red Light Therapy Mask for Face and Neck", "tie": "other", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K261407", "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261407", "note": "FDA's device listing names iFae LED masks under K261407, but that filing lists other model numbers, so we could not confirm this one.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "FDA's device listing names iFae LED masks under K261407, but that filing lists other model numbers, so we could not confirm this one.", "seller": "inSkinBeauty", "price": 149.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0fssmbj44-16tc4em/", "fda_finding": "Brand has a clearance, not for this model" }, { "rank": 58, "asin": "B09WB6PWCC", "brand": "HigherDOSE", "name": "Red Light Face Mask", "tie": "tied", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "HigherDOSE Red Light Therapy Mask, FSA Eligible, FDA Cleared LED Face Mask", "claim_url": null, "k_number": "K241933", "filing_device": "HIGHERDOSE Red and Infrared Light Mask (MK66-L)", "filed_by": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decided": "2024-09-27", "cleared_for": "wrinkles", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241933.pdf", "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "FDA filing K241933 ('HIGHERDOSE Red and Infrared Light Mask (MK66-L)', filed by Shenzhen Kaiyan Medical Equipment Co., Ltd.) names this brand or mask.", "seller": "Prime Ledger Supply", "price": 249.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": false, "listing_url": null, "fda_finding": "FDA filing tied to this mask" }, { "rank": 59, "asin": "B0GY3PXCV5", "brand": "NOOANCE", "name": "Elite X600", "tie": "tied", "live": true, "says_fda": true, "claim_where": "bullets", "claim_quote": "Target Fine Lines and Wrinkles: The FDA-cleared Elite X600 red light therapy mask for face treats full-face wrinkles with 600…", "claim_url": "https://verifiedbeautydata.com/go/b0gy3pxcv5-1ecddlq/", "k_number": "K260150", "filing_device": "NOOANCE LED Facial Mask Elite X600 (MJ-66C)", "filed_by": "Shenzhen Kaiyan, and NOOANCE's own filing lists that model", "decided": null, "cleared_for": "wrinkles", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260150", "note": "Listed with FDA as \"NOOANCE LED Facial Mask Elite X600 (MJ-66C)\" under K260150 by Shenzhen Kaiyan, and NOOANCE's own filing lists that model.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "Listed with FDA as \"NOOANCE LED Facial Mask Elite X600 (MJ-66C)\" under K260150 by Shenzhen Kaiyan, and NOOANCE's own filing lists that model.", "seller": "NOOĀNCE Paris", "price": 749, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0gy3pxcv5-1ecddlq/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gy3pxcv5-1ecddlq/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 60, "asin": "B0HDCHZHW6", "brand": "MICEYLIVE", "name": "4D Wireless Red Light Therapy Mask", "tie": "possible", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "4D Wireless Red Light Therapy Mask, FDA-Cleared Blue Light Mask for Acne", "claim_url": "https://verifiedbeautydata.com/go/b0hdchzhw6-0u0b7al/", "k_number": "K243555", "filing_device": "LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)", "filed_by": "Shenzhen Eyco Technology Co., Ltd.", "decided": "2025-02-05", "cleared_for": "both (acne primary, wrinkles secondary)", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243555.pdf", "note": "The listing's model (E43) is in filing K243555 by Shenzhen Eyco Technology Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing's model (E43) is in filing K243555 by Shenzhen Eyco Technology Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "seller": "MINXINHOLDINGS", "price": 169.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0hdchzhw6-0u0b7al/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0hdchzhw6-0u0b7al/", "fda_finding": "Factory filing, brand not named" }, { "rank": 61, "asin": "B0H1GMT9QS", "brand": "NOMADARA", "name": "Red Light Therapy Mask for Face", "tie": "possible", "live": true, "says_fda": true, "claim_where": "bullets", "claim_quote": "A reliable choice for users looking for an FDA-cleared LED face mask for daily skincare routines", "claim_url": "https://verifiedbeautydata.com/go/b0h1gmt9qs-15io1w9/", "k_number": "K253054", "filing_device": "LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)", "filed_by": "Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.", "decided": "2025-12-19", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253054.pdf", "note": "The listing's model (M19) is in filing K253054 by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing's model (M19) is in filing K253054 by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "seller": "Iceberg Toys", "price": 109.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0h1gmt9qs-15io1w9/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h1gmt9qs-15io1w9/", "fda_finding": "Factory filing, brand not named" }, { "rank": 62, "asin": "B0GWPYBHC7", "brand": "Sojuvenver", "name": "Red Light Therapy Mask for Face", "tie": "claim", "live": true, "says_fda": true, "claim_where": "bullets", "claim_quote": "8-in-1 LED Light Therapy for Skin: This 510(k)-cleared LED face mask set features 8 treatment modes, including 850nm near-infrared…", "claim_url": "https://verifiedbeautydata.com/go/b0gwpybhc7-14ojya0/", "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": "The listing says FDA cleared. We found no filing that names the brand, and it shows no model or K number we could check.", "fda_rechecked": true, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing says FDA cleared. We found no filing that names the brand, and it shows no model or K number we could check.", "seller": "Sojuvenver-US", "price": 129.98, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gwpybhc7-14ojya0/", "fda_finding": "Says FDA, no record found" }, { "rank": 63, "asin": "B0GSZ53SZT", "brand": "Deccasa", "name": "4 Light Red Light Face & Neck Mask", "tie": "none", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": null, "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "No FDA record matches the brand, seller, maker or model.", "seller": "Deccasa", "price": 59.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gsz53szt-0h2d89a/", "fda_finding": "No FDA claim, no record found" }, { "rank": 64, "asin": "B0FWBRSD19", "brand": "Ulike", "name": "ReGlow Lite", "tie": "tied", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K243555", "filing_device": "LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)", "filed_by": "Shenzhen Eyco Technology Co., Ltd.", "decided": "2025-02-05", "cleared_for": "both (acne primary, wrinkles secondary)", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243555", "note": "Ulike International's own FDA listing under K243555 reads 'LED light therapy mask, Model: E100B', the Amazon model.", "fda_rechecked": false, "corrected": true, "finding_before": "Likely filing, not tied to this mask", "evidence": "openFDA registrationlisting K243555, firm ULIKE INTERNATIONAL INDUSTRIAL PTE. LTD.: 'LED light therapy mask, Model: E100B'. Amazon model E100B, maker Shenzhen Eyco.", "reason": "Ulike International's own FDA listing under K243555 reads 'LED light therapy mask, Model: E100B', the Amazon model.", "seller": "Ulike Official US", "price": 149, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0fwbrsd19-0szsefn/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0fwbrsd19-0szsefn/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 65, "asin": "B0FQTT5RNR", "brand": "CoolPump", "name": "Upgraded Red Light Therapy Mask for Face and", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K253054", "filing_device": "LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)", "filed_by": "Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.", "decided": "2025-12-19", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253054.pdf", "note": "The listing's model (M19-6) is in filing K253054 by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing's model (M19-6) is in filing K253054 by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "seller": "CoolPump-US", "price": 29.85, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0fqtt5rnr-1e5n63f/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0fqtt5rnr-1e5n63f/", "fda_finding": "Factory filing, brand not named" }, { "rank": 66, "asin": "B0FWKSFSVS", "brand": "FOREO FAQ", "name": "202 Plus", "tie": "tied", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K240378", "filing_device": "FAQ 202 Plus", "filed_by": "FOREO", "decided": null, "cleared_for": "wrinkles and acne", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240378", "note": "Listed with FDA as \"FAQ 202 Plus\" under K240378 by FOREO.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "Listed with FDA as \"FAQ 202 Plus\" under K240378 by FOREO.", "seller": "FOREO", "price": 1099, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b0fwksfsvs-1lbfd74/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0fwksfsvs-1lbfd74/", "fda_finding": "FDA filing tied to this mask" }, { "rank": 67, "asin": "B0DJQKVW64", "brand": "Project E Beauty", "name": "LumaLux Face", "tie": "other", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K214101", "filing_device": "Project E Beauty LED Light Therapy Mask (Model: PE730)", "filed_by": "Duplex International Trading Limited", "decided": "2022-03-23", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K214101.pdf", "note": "Project E Beauty has clearances for other models. This mask's model, PE727, is not among them.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "Project E Beauty has clearances for other models. This mask's model, PE727, is not among them.", "seller": "Project E Beauty", "price": 369, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0djqkvw64-0rd1yk6/", "fda_finding": "Brand has a clearance, not for this model" }, { "rank": 68, "asin": "B0H38N4R56", "brand": "LBO", "name": "Red Light Therapy Mask for Face & Neck", "tie": "possible", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "LBO LED-FDA-Cleared Red Light Therapy Mask for Face & Neck redlight FaceMask Treatment of full-face wrinkles Blue light Treatmentof mild to moderate inflammatory acne, USB-C, Remote Control, M19-6", "claim_url": null, "k_number": "K253054", "filing_device": "LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)", "filed_by": "Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.", "decided": "2025-12-19", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253054.pdf", "note": "The listing's model (M19-6) is in filing K253054 by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing's model (M19-6) is in filing K253054 by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., but no FDA record names the brand and the listing gives no K number.", "seller": "LBO-US", "price": 49.98, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": false, "listing_url": null, "fda_finding": "Factory filing, brand not named" }, { "rank": 69, "asin": "B0H1MLFB78", "brand": "Zeepeak", "name": "3D Red Light Therapy for Face", "tie": "claim", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "FDA-Cleared 3D Red Light Therapy for Face, 6 Modes, Deep Dual NIR, 360 LEDs", "claim_url": "https://verifiedbeautydata.com/go/b0h1mlfb78-15gncqg/", "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": "The listing says FDA cleared. We found no filing that names the brand, and it shows no model or K number we could check.", "fda_rechecked": true, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing says FDA cleared. We found no filing that names the brand, and it shows no model or K number we could check.", "seller": "Zeepeak", "price": 499.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h1mlfb78-15gncqg/", "fda_finding": "Says FDA, no record found" }, { "rank": 70, "asin": "B0GL2H3HL5", "brand": "Aiscool", "name": "Red Light Therapy Mask for Face", "tie": "claim", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "Red Light Therapy Mask for Face, FDA-Cleared 324 LEDs Full Face Coverage", "claim_url": "https://verifiedbeautydata.com/go/b0gl2h3hl5-0a0p3z4/", "k_number": null, "filing_device": null, "filed_by": null, "decided": null, "cleared_for": null, "filing_url": null, "note": "The listing says FDA cleared. We found no filing that names the brand, and it shows no model or K number we could check.", "fda_rechecked": true, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing says FDA cleared. We found no filing that names the brand, and it shows no model or K number we could check.", "seller": "Yuwende", "price": 109.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0gl2h3hl5-0a0p3z4/", "fda_finding": "Says FDA, no record found" }, { "rank": 71, "asin": "B09FLJDNB8", "brand": "NEWKEY", "name": "Blue Light Therapy Mask for Acne", "tie": "possible", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K220168", "filing_device": "Skin Care Beauty Mask (Model: MJ-06)", "filed_by": "Shenzhen Kaiyan Medical CO , Ltd.", "decided": "2022-05-17", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220168.pdf", "note": "The listing's model (MJ-06) is in filing K220168 by Shenzhen Kaiyan Medical CO , Ltd., but no FDA record names the brand and the listing gives no K number.", "fda_rechecked": false, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing's model (MJ-06) is in filing K220168 by Shenzhen Kaiyan Medical CO , Ltd., but no FDA record names the brand and the listing gives no K number.", "seller": "NEWKEY", "price": 189.99, "buyable": true, "amazon_checked": "2026-10-26", "detail_url": "https://verifiedbeautydata.com/go/b09fljdnb8-0jk7psg/", "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b09fljdnb8-0jk7psg/", "fda_finding": "Factory filing, brand not named" }, { "rank": 72, "asin": "B0H757ZFL1", "brand": "Aureskyn", "name": "Red Light Therapy for Face 4-Mode LED Mask", "tie": "possible", "live": true, "says_fda": true, "claim_where": "bullets", "claim_quote": "FDA 510K cleared", "claim_url": "https://verifiedbeautydata.com/go/b0h757zfl1-1gdvt37/", "k_number": "K253054", "filing_device": "LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)", "filed_by": "Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.", "decided": "2025-12-19", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253054", "note": "Amazon names Shenzhen Xinlong as maker and part number M19-3, a model in Xinlong's filing K253054. No FDA record names Aureskyn, and the listing gives no K number.", "fda_rechecked": true, "corrected": true, "finding_before": "Says FDA, no record found", "evidence": "Amazon maker 'Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.', part number M19-3; K253054 device name lists M19-3. No record names Aureskyn.", "reason": "Amazon names Shenzhen Xinlong as maker and part number M19-3, a model in Xinlong's filing K253054. No FDA record names Aureskyn, and the listing gives no K number.", "seller": "Creative Living Shop", "price": 109.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h757zfl1-1gdvt37/", "fda_finding": "Factory filing, brand not named" }, { "rank": 73, "asin": "B0HGG15DNB", "brand": "Pure Daily Care", "name": "Luma Mask Ultra LED Face & Neck Light", "tie": "other", "live": true, "says_fda": false, "claim_where": null, "claim_quote": null, "claim_url": null, "k_number": "K243555", "filing_device": "LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)", "filed_by": "Shenzhen Eyco Technology Co., Ltd.", "decided": "2025-02-05", "cleared_for": "both (acne primary, wrinkles secondary)", "filing_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243555", "note": "FDA listing under K243555 names 'Pure Daily Care LUMA Light LED Therapy Facial Mask (Model: E43)'; this listing ('Luma Mask Ultra', face and neck) shows no model to confirm it is that mask.", "fda_rechecked": false, "corrected": true, "finding_before": "No FDA claim, no record found", "evidence": "openFDA registrationlisting K243555 (Shenzhen Eyco): 'Brand: Pure Daily Care LUMA Light LED Therapy Facial Mask (Model:E43)'. This Amazon listing ('Luma Mask Ultra', face and neck) shows no model number.", "reason": "FDA listing under K243555 names 'Pure Daily Care LUMA Light LED Therapy Facial Mask (Model: E43)'; this listing ('Luma Mask Ultra', face and neck) shows no model to confirm it is that mask.", "seller": "Aquasonic Official", "price": 199.95, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0hgg15dnb-1lovgux/", "fda_finding": "Brand has a clearance, not for this model" }, { "rank": 74, "asin": "B0H38XC33N", "brand": "EUARNE", "name": "Red Light Therapy for Face", "tie": "possible", "live": true, "says_fda": true, "claim_where": "title", "claim_quote": "Red Light Therapy for Face, 324 LEDs FDA Cleared", "claim_url": "https://verifiedbeautydata.com/go/b0h38xc33n-058clk3/", "k_number": "K250413", "filing_device": "Aglaia LED Beauty Device (BP-D2309)", "filed_by": "Shenzhen Perfect Idea Technology Limited", "decided": "2025-03-18", "cleared_for": "both", "filing_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250413.pdf", "note": "The listing cites K250413, a factory's clearance for its LED masks. The listing shows no model number, so we could not tie it to that filing.", "fda_rechecked": true, "corrected": false, "finding_before": null, "evidence": null, "reason": "The listing cites K250413, a factory's clearance for its LED masks. The listing shows no model number, so we could not tie it to that filing.", "seller": "EUARNE US", "price": 129.99, "buyable": false, "amazon_checked": "2026-10-26", "detail_url": null, "in_stock": true, "listing_url": "https://verifiedbeautydata.com/go/b0h38xc33n-058clk3/", "fda_finding": "Factory filing, brand not named" } ] }