Only 9 of 24 Amazon LED face masks that say "FDA cleared" have an FDA filing tied to that mask

1. 74best-selling LED face masks on Amazon in our sample
2. 71still for sale when we re-checked on October 13, 2026
3. 24of those say "FDA cleared" or "510(k) cleared" in the title or bullet points
4. 9 filing tied to that exact mask 11 point to a factory's filing that does not name the brand 4 no FDA record found

The other side of it: 22 of the 74 masks have an FDA filing tied to them. Ten of the 19 still for sale do not mention FDA in their Amazon listing at all. A missing "FDA" on the listing does not mean a mask is not cleared.

Quotes are from each Amazon listing on October 13, 2026, highest price first. No record found does not prove none exists; a brand may hold a filing under another name. If you make one of these masks, send us the K number and we will check it and update this page. We do not link these masks to buy.

Many LED masks are made in a few factories and sold under many brand names. The factory files with FDA. The brand on the box may not appear anywhere in FDA's records. Of the 14 brands on the first two filings below, 4 are tied to the filing.

"Tied" means FDA's 510(k) or device listing names that brand or mask, or the brand gives the K number and its model is in the filing. Federal rules ask the company that lists a device to list every brand name it is sold under (21 CFR 807.25(g)(3)). A brand that is not named may still sell the cleared mask; FDA's records just do not say so, so a shopper cannot check it.

• The same model, different prices. CoolPump sells a mask listed as model M19-6 for $29.85, LBO sells a mask listed as model M19-6 for $49.98 and BONLIBRO sells a mask listed as model M19-6 for $62.99 on Amazon (prices seen October 26, 2026). M19-6 is one of the models in Shenzhen Xinlong's filing (K253054).
• Premium brands use factories too. Shenzhen Kaiyan Medical filed the clearances for CurrentBody's Series 2 mask and the HigherDOSE mask. Its FDA device listings name 64 brands of light devices, among them CurrentBody, HigherDOSE, Solawave, NOOANCE, Qure, BON CHARGE, FaceGym, Angela Caglia, Hammacher Schlemmer and Walgreens. Source: FDA's Registration & Listing database, read October 13, 2026.

FDA clears LED masks for wrinkles, acne or both. None of the 214 clearances we read lists collagen in its "Indications for Use." FDA has dealt with this claim before: on June 29, 2018, Quasar Bio-Tech recalled three cleared light devices (Baby Quasar Plus, Quasar MD Plus, Pure Rayz) because, in FDA's record, Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. We do not say any listing below breaks a rule. We show what each one says.

Quotes are from each Amazon listing's title or bullet points on October 13, 2026. We counted a listing only when it says the mask itself builds, boosts or stimulates collagen (one listing that bundles a collagen serum is left out). FDA recall Z-2973-2018, Z-2974-2018, Z-2975-2018, cleared under K130225: FDA record. A second recall, by Accord Media in 2017, was for distribution of medical devices with unapproved green LED light used to treat hyperpigmentation (FDA record).

We read every report in FDA's device injury database (MAUDE) filed under the two product codes LED face masks are cleared under: 158 reports, 140 of them injuries. Reports for light-based wrinkle devices went from 5 in 2024 to 37 in 2025 and 49 so far in 2026 (through August 21, 2026). Most of the rise is one mask: without the Shark CryoGlow, the count was 11 in 2025 and 6 so far in 2026.

• 69 reports are about the Shark CryoGlow, the best-selling mask in our sample (Amazon shows "4K+ bought in past week"). It has a real FDA clearance (K242796). Most reports describe skin reactions such as redness, rash, burning or irritation, or swelling around the eyes; 30 mention a doctor or treatment. 31 say the event happened outside the US. SharkNinja filed 68 of them itself, as device makers must.
• 42 reports are about Neutrogena's light therapy acne mask, received from November 2017 to May 2023.
• Other masks in our sample with any report: Omnilux (4), HigherDOSE (2) and CurrentBody (1).
• No report names any of the masks with no FDA record, or any brand that sells under a factory's filing. That does not mean they are safer. 115 of the 158 reports were filed by device makers. A brand that is not in FDA's records is hard to trace.

An injury report is one person's account. It does not prove the device caused the harm, and more sales mean more reports. Source: FDA MAUDE through openFDA, product codes OHS and OLP, pulled October 13, 2026 (query); brand searches across all product codes.

“A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.”

• Cleared, not approved. Federal rules say a 510(k) clearance does not in any way denote official approval of the device (21 CFR 807.97). No LED face mask is "FDA approved."
• Cleared for a use. Each clearance names what the mask is for: wrinkles, mild to moderate acne, or both. A mask cleared for wrinkles is not cleared for acne.
• No trial needed. The CurrentBody Series 2 filing (K250966) says Clinical testing is not needed for this 510(k). Read it. The Omnilux Contour (filed as faceLITE) filing (K191629) says clinical data is not required. Read it.
• The paperwork often names a factory, not the brand. Many clearances are filed by the factory that makes the mask, and one factory model can be sold under many brand names (see above).
• "FDA approved" is the wrong word. The box of one mask in our sample, the BONLIBRO Red Light Therapy Mask for Face, shows an "FDA APPROVED" seal in its Amazon photos (seen October 13, 2026). Its factory's clearance is real (K253054). But no LED mask is approved; they are cleared.

1. Find the K number. It is a K plus six digits, on the box, manual or brand site. No K number? Ask the brand.
2. Search it in FDA's 510(k) database.
3. Match the model. The device name or model number in the filing should match your mask.
4. Read "Indications for Use." That line says what the mask is cleared for.

• Best overall: Shark CryoGlow FDA cleared (K242796) for wrinkles and acne. Sold by Amazon.com. Buy on Amazon $339.99
• Best for less: RENPHO Rejuven FDA cleared (K243555) for both (acne primary, wrinkles secondary). Sold by Smartindex. Buy on Amazon $169.99

Amazon prices checked October 26, 2026. Some links earn us a commission. It does not change which masks are listed.

• Sample. The 74 best-selling LED face masks on amazon.com by Amazon sales rank (Beauty & Personal Care), drawn October 4, 2026. We removed neck-only, chest-only and bundle listings so each mask counts once.
• What we read on Amazon. Each listing's title, bullet points, brand, seller, the maker Amazon names, and its model and part number (Amazon's product data), plus every photo of the 24 listings that say FDA, read one by one for K numbers, model numbers and FDA wording. Listings re-read October 13, 2026.
• FDA records. We downloaded FDA's complete records for the product codes LED masks are cleared under (OHS for wrinkles, OLP for acne, ILY for infrared lamps): all 443 510(k) clearances, the text of 397 decision letters and summaries, and 962 FDA device listings (through openFDA, October 13, 2026). We searched all of it for every mask's brand, seller, maker, trade name and each model or part number, ignoring case, spaces and hyphens. Every K number in the data links to FDA's record.
• "Tied to this mask" means an FDA record links the brand to the mask: a 510(k) filing or FDA device listing names the brand or mask (and any model the listing shows is in that same filing or listing), or the brand gives a K number and the listing's model is in that filing. A model number that matches a factory's filing is not enough on its own; those masks are "Factory filing, brand not named."
• "No FDA record found" means nothing in FDA's records matched the brand, seller, maker, trade name or any model number. It is an unconfirmed claim, not proof of a false one: a brand can sell a cleared device under a name its factory never listed.
• "Says FDA" means the Amazon title or bullet points say "FDA" or "510(k)." 3 listings in the sample were no longer on Amazon on October 13, 2026, so they are left out of the 71.
• Limits. No record found does not prove a mask has no clearance. FDA device listings are filed by companies; FDA does not check each brand name in them. We did not test any mask. Amazon listings and prices change daily. Some buy links on this site earn a commission; that does not change the findings.
• Reproduce it. The CSV has, for every mask, the K number, a link to FDA's record, the reason for its group and, for the 15 masks our re-check moved, the earlier finding and the evidence.

• October 13, 2026 Added (night): which listings sell the mask on collagen, two FDA recalls over the same kind of claim, what FDA's injury reports show, the brands in one factory's FDA listings, and Amazon's own sales badges. Sources and data are listed in each section.
• October 13, 2026 Corrected (evening). We re-ran the check against FDA's complete records for LED masks: every clearance under product codes OHS, OLP and ILY (443), the text of 397 filing PDFs and 962 FDA device listings, plus each listing's Amazon part number and photos. 15 masks changed group. Of the 24 listings that say "FDA cleared," 6 → 9 have a filing tied to the mask, and 8 → 4 have no FDA record found. Our first pass did not use Amazon's part-number field or every FDA device listing. Each changed row is marked in the data, with its earlier finding.
• October 13, 2026 Published. All 74 listings re-read and every mask whose listing says FDA searched again at FDA. Three masks moved out of "no record found" after the re-check (see our corrections page).

Which LED face masks on Amazon are really FDA cleared?

Of the 74 best-selling masks we checked, 22 have an FDA filing or device listing tied to that exact mask, whether or not the listing says so. They include the Shark CryoGlow, the RENPHO Rejuven and the CurrentBody LED Light Therapy Mask Series 2. The full list, with each K number, is in the download on this page.

Is the Dr. Dennis Gross LED mask FDA cleared?

Dr. Dennis Gross says the SpectraLite FaceWare Pro is FDA cleared, and its Amazon listing says "Dermatologist-developed and FDA cleared." The brand gives no K number, and no FDA 510(k) filing or device listing we searched names Dr. Dennis Gross, SpectraLite or FaceWare Pro (checked October 13, 2026). The closest FDA record is K183247, the "dpl Faceware" from LED Technologies, Inc, cleared for wrinkles and acne, with the same 3-minute treatment. The same company also holds K171386, the "dpl SpectraLite," cleared only for wrinkles around the eyes. Nothing in FDA's records ties either one to Dr. Dennis Gross. If the brand shares its K number, we will update this page.

Why isn't a mask "tied" when its model number is in an FDA filing?

Many clearances are filed by a factory, and the same factory model is sold under many brand names. Two factory filings in our sample cover 15 best-selling masks sold under 14 brand names, and only 4 of those brands are tied to the filing. Amazon's model field is typed in by the seller. So we count a mask as tied only when an FDA record links the brand to it: FDA names the brand or mask, or the brand gives the K number and its model is in that filing. A model match alone is "Factory filing, brand not named." The mask may well be the cleared one; FDA's records just do not say so for that brand.

What is the difference between FDA cleared and FDA approved?

LED masks are "cleared," not "approved." Clearance (a 510(k)) means FDA agreed the mask is similar enough to a device already sold. Approval is a stricter process for high-risk devices. No LED face mask is "FDA approved."

Does FDA clearance mean an LED mask works?

Not by itself. FDA clears a mask for a use, such as wrinkles or mild acne, based on its similarity to an older device. CurrentBody's Series 2 filing says "Clinical testing is not needed for this 510(k)." Omnilux's says "clinical data is not required."

How do I check if an LED mask is FDA cleared?

Find the K number (K plus six digits) on the box, manual or brand site. Search it in FDA's 510(k) database. Check that the device name or model number matches your mask. Read the "Indications for Use" line: that is what it is cleared for. If the brand gives no K number, ask for it.

Can I use this data and these charts?

Yes. The data and charts are free to use under CC BY 4.0. Please credit Verified Beauty Data and link to this page.