Is Omnilux FDA approved?

No LED mask is "FDA approved." The Omnilux Contour is FDA cleared, for wrinkles. FDA's device listing names the Omnilux Contour under K191629, a clearance from September 12, 2019 filed under the name "faceLITE." The same clearance is listed for 20 product names. It does not cover acne.

Is the Dr. Dennis Gross LED mask FDA approved?

LED masks are cleared, not approved. Dr. Dennis Gross says the SpectraLite FaceWare Pro is FDA cleared, but it does not publish a K number, and no FDA filing or device listing we searched names Dr. Dennis Gross, SpectraLite or FaceWare Pro. The closest FDA record is K183247, the "dpl Faceware" from LED Technologies, cleared March 14, 2019 for wrinkles and acne. It has the same 3-minute treatment and similar light colors, but nothing in FDA's records ties it to Dr. Dennis Gross.

Is the Shark CryoGlow FDA approved?

It is FDA cleared (masks are cleared, not approved). FDA cleared it on November 27, 2024 under K242796, filed by SharkNinja itself. It covers fine lines and wrinkles (red and infrared light) and mild to moderate inflammatory acne (red, blue and infrared light).

Is CurrentBody FDA approved?

It is FDA cleared, not approved. The Series 2 was cleared for full-face wrinkles on June 25, 2025 (K250966). The Series 3 was cleared on June 3, 2026 (K260715): its blue and red mode for acne, its yellow and near-infrared mode for wrinkles, and its red and infrared mode for easing minor muscle and joint pain, not wrinkles.

Is the Solawave LED mask FDA cleared?

Yes, for wrinkles. FDA cleared the "Wrinkle Retreat Pro Light Therapy Face Mask" on December 17, 2025 under K252983. A factory filed it under the product's name; Solawave's name is not on the filing, but Solawave's own site gives this number. It does not cover acne.

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 one already sold, mostly on safety. FDA does not test whether it works. The Omnilux and CurrentBody Series 2 filings both say clinical data was not needed. Approval is a stricter process used for high-risk devices.

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

Find the mask's K number (a 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 matches your mask and read the "Indications for Use" line: that is what the clearance covers. If the brand gives no K number, ask for it.

Which LED face masks are FDA cleared?

10 of the 11 best-known LED face masks sold in the US have an FDA 510(k) clearance we could tie to them. The exception is the Dr. Dennis Gross DRx SpectraLite FaceWare Pro: the brand says it is FDA cleared, but it gives no K number and no FDA record names it.

Our pick: cleared for wrinkles and acne

Shark CryoGlow $299 Amazon, Oct 7, 2026

FDA cleared it for wrinkles and acne in 2024 (K242796), in Shark's own name. Sold by Amazon.

Buy on Amazon $299

Under $150: the LifePro RevitaGlow ($149.99, sold by Amazon), cleared for both through its factory's filing. Amazon links may earn us a commission; it does not change what we found.

01 / The list

11 LED face masks, their FDA K numbers, and what each clearance covers

From FDA's 510(k) database and device listings, read October 7, 2026. Each K number links to the FDA filing. "Cleared for" is FDA's wording, shortened; the exact sentence is in the photo of each filing further down. Amazon prices and sellers are from Amazon's product data on October 7, 2026.

Mask	FDA 510(k)	Cleared for	Whose name it is under	Cleared on	On Amazon, Oct 7, 2026
SharkCryoGlow	K242796Filing names it	wrinkles and acne	SharkNinja Operating, LLC	Nov 27, 2024	$299, sold by AmazonBlue Frost color. The Lilac Chill color (B0DYG4Q6PL) was out of stock.
CurrentBodyLED Mask Series 2	K250966Filing names it	wrinkles	Shenzhen Kaiyan Medical Equipment (its maker)	Jun 25, 2025	$469.99, sold by the brand (The Beauty Tech Group Ltd (CurrentBody's company))
CurrentBodyLED Mask Series 3	K260715Filing names it	acne (blue + red mode), wrinkles (yellow + near-infrared mode), and minor muscle and joint pain (red + infrared mode)	The Beauty Tech Group (CurrentBody's company)	Jun 3, 2026	Not on Amazon. $569.99 from CurrentBody
OmniluxContour Face	K191629FDA listing names it	wrinkles	Ismart Marketing Svcs, Ltd.	Sep 12, 2019	$442.99, sold by a reseller (Posh Gifts Online), not the brand
TherabodyTheraFace Mask and Mask Glo	K230293Filing names it	wrinkles and acne	Therabody, Inc.	Jun 9, 2023	$559.99, sold by the brand (TheraGun (Therabody's store))TheraFace Mask. The Mask Glo (B0FKD3826X) was out of stock.
SolawaveWrinkle Retreat Pro	K252983Filing names the product	wrinkles	Shenzhen Goodwind Technology (a factory)	Dec 17, 2025	$255.85, sold by a reseller (null), not the brandSolawave's face-mask listing had no offer. A face-and-neck set (B0GSSG9LS3) was $377.58 from SolaWave; we could not confirm which face mask is in it.
HigherDOSERed Light Face Mask	K241933Filing names it	wrinkles	Shenzhen Kaiyan Medical Equipment (its maker)	Sep 27, 2024	$269.99, sold by a reseller (FRONT ROW), not the brand
QureQ-Rejuvalight Pro	K230042Filing names it	wrinkles and acne	Light Tree Ventures Europe B.V.	Apr 28, 2023	$399, sold by the brand (Qure Skincare)
UlikeReGlow	K243492Filing names it	wrinkles and acne	Shenzhen Ulike Smart Electronics Co., Ltd.	Jan 10, 2025	$259, sold by the brand (Ulike Official US)
LifeProRevitaGlow	K233114Filing lists its model	wrinkles and acne	Shenzhen Idea Light Limited (a factory)	Jan 12, 2024	$149.99, sold by Amazon
Dr. Dennis GrossDRx SpectraLite FaceWare Pro	None foundNo FDA record found	Not confirmed (the brand says wrinkles and acne)	No FDA record names it	n/a	$455, sold by the brand (Dr. Dennis Gross Skincare, LLC)

LightStim sells no LED face mask. Its home devices are handhelds (LightStim for Wrinkles and LightStim for Acne) and the Elipsa. FDA cleared the two handhelds again on July 31, 2026 (K261482). LightStim's product list. Cleared for both acne and wrinkles: Shark, CurrentBody Series 3, Therabody, Qure, Ulike and LifePro. Wrinkles only: CurrentBody Series 2, Omnilux, Solawave and HigherDOSE. We link only masks sold on Amazon by Amazon or the brand itself.

02 / What "FDA cleared" means

Cleared is not approved, and it does not mean FDA tested it

No LED mask is "FDA approved." Masks go through a 510(k): the maker shows FDA the mask is similar to one already sold. FDA "clears" it, mostly on safety.
FDA does not test whether it works. The Omnilux (faceLITE) filing says "clinical data is not required," and the CurrentBody Series 2 filing says "Clinical testing is not needed for this 510(k)."
A clearance covers only what it says. Read the "Indications for Use" line. 4 of the masks above are cleared for wrinkles only, so an acne claim on the box is not covered.

03 / What the box will not tell you

Three things we found in the FDA records

1. Many filings are in a factory's name

At least 4 of the 10 clearances were filed by a factory, not the brand on the box. One factory, Shenzhen Kaiyan Medical Equipment, filed for both the CurrentBody Series 2 and the HigherDOSE mask.
2. One clearance can cover many brands

FDA's listing ties 20 product names to the Omnilux clearance (K191629), including ELEMIS and PRIORI masks. Another, K221775, is listed for 40 names, including Solawave's earlier Wrinkle Retreat mask, Bon Charge and MitoGLOW.
3. One mode can be cleared for something else

On the CurrentBody Series 3, the red and infrared mode is cleared for heat to ease minor muscle and joint pain, not for wrinkles. Its wrinkle clearance is for the yellow and near-infrared mode. The filing also says it is meant for skin types I to IV.

04 / The one we could not confirm

Dr. Dennis Gross says "FDA cleared." We could not find the record.

Dr. Dennis Gross's product page says "This device is FDA Cleared!" and does not give a K number. We searched FDA's 510(k) database and device listings for Dr. Dennis Gross, SpectraLite, FaceWare and the product's name. Nothing names it. The closest record is K183247, the "dpl Faceware" from LED Technologies, Inc., cleared March 14, 2019 for wrinkles and acne. It has the same 3-minute treatment and the same light colors Dr. Dennis Gross lists (605 nm amber, 630 nm red, 880 nm near-infrared, 415 nm blue; the filing adds 660 nm red). Nothing in FDA's records ties it to Dr. Dennis Gross. That does not mean the mask is not cleared. It means you cannot check it. More in Dr. Dennis Gross vs Omnilux.

05 / The records

What each FDA filing says, in FDA's own words

Each image is the "Indications for Use" page of the filing, cropped. Tap it to open the full filing on fda.gov.

Shark CryoGlow K242796

"The CryoGlow LED mask emits energy in the red and infrared light spectrum for the treatment of fine lines and wrinkles and in the red, blue, and infrared light spectrum for the treatment of mild-to-moderate inflammatory acne."

The filing is in Shark's own name and names the CryoGlow.
CurrentBody LED Mask Series 2 K250966

"The CurrentBody Skin LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles."

Filed by the factory that makes it, under CurrentBody's product name.
CurrentBody LED Mask Series 3 K260715

"Mode 2 (including blue (415nm) & red (633nm)) is intended for the treatment of mild to moderate inflammatory acne. Mode 3 (including yellow (590nm) & NIR (830nm)) is intended for the treatment of full face wrinkles."

Filed by CurrentBody's company. FDA's device listing names it "CurrentBody LED Light Therapy Mask: Series 3."
Omnilux Contour Face K191629

"The faceLITE LED mask is an over the counter device that is intended for the use in the treatment of full-face wrinkles."

Filed as "faceLITE." FDA's device listing names the Omnilux Contour under this number, along with 19 other product names.
Therabody TheraFace Mask and Mask Glo K230293

"Red Light is intended to treat full face wrinkles. Blue Light is intended to treat mild to moderate inflammatory acne. Red + Infrared Light is intended to treat full face wrinkles."

The filing is in Therabody's own name. FDA's device listing names both the TheraFace Mask and the Mask Glo.
Solawave Wrinkle Retreat Pro K252983

"The Wrinkle Retreat Pro Light Therapy Face Mask is an Over-the-Counter (OTC) device intended for use in treating full-face wrinkles."

Filed by a factory under the mask's product name. Solawave's name is not on the filing; Solawave's own site cites this number.
HigherDOSE Red Light Face Mask K241933

"The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles."

Filed by the factory that makes it, under HigherDOSE's name.
Qure Q-Rejuvalight Pro K230042

"The Q-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne."

The filing names the Q-Rejuvalight Pro Facewear.
Ulike ReGlow K243492

"Ulike Reglow Light Therapy Device is an over the counter device that is intended for use in the treatment of full face wrinkles and treatment of mild to moderate inflammatory acne."

The filing is in Ulike's own name.
LifePro RevitaGlow K233114

"LED silicone mask (Models: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. [...] intended for the use in the treatment of full-face wrinkles."

Filed by a factory. The filing lists LifePro's RevitaGlow model numbers (LP-RVTGLW-WHT, and LP-RVTGLWP-WHT for the Pro); LifePro's name is not on it.
dpl Faceware (closest match to Dr. Dennis Gross, not confirmed) K183247

"The dpl® Faceware is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne."

06 / Who should buy which

Which FDA-cleared mask fits you

Acne and lines, sold by Amazon: Shark CryoGlow, $299.
Acne and lines, under $150: LifePro RevitaGlow, $149.99.
Lines only, softer silicone fit: CurrentBody Series 2, $469.99, or the Omnilux Contour Face for $395 from Omnilux. See Omnilux vs CurrentBody.
Darker skin, or a medicine that makes you sensitive to light: talk to a dermatologist first. The American Academy of Dermatology says darker skin can be more sensitive to visible light.

For more picks and measured light output, see our LED mask buyer's guide (74 Amazon masks checked).

07 / Questions

Frequently asked

Which LED face masks are FDA cleared?: Of the 11 big-name masks we checked on October 7, 2026, these have an FDA clearance tied to them: Shark CryoGlow (K242796), CurrentBody LED Mask Series 2 (K250966), CurrentBody LED Mask Series 3 (K260715), Omnilux Contour Face (K191629), Therabody TheraFace Mask and Mask Glo (K230293), Solawave Wrinkle Retreat Pro (K252983), HigherDOSE Red Light Face Mask (K241933), Qure Q-Rejuvalight Pro (K230042), Ulike ReGlow (K243492) and LifePro RevitaGlow (K233114). The Dr. Dennis Gross DRx SpectraLite FaceWare Pro says it is cleared, but we found no FDA record that names it.
Is Omnilux FDA approved?: No LED mask is "FDA approved." The Omnilux Contour is FDA cleared, for wrinkles. FDA's device listing names the Omnilux Contour under K191629, a clearance from September 12, 2019 filed under the name "faceLITE." The same clearance is listed for 20 product names. It does not cover acne.
Is the Dr. Dennis Gross LED mask FDA approved?: LED masks are cleared, not approved. Dr. Dennis Gross says the SpectraLite FaceWare Pro is FDA cleared, but it does not publish a K number, and no FDA filing or device listing we searched names Dr. Dennis Gross, SpectraLite or FaceWare Pro. The closest FDA record is K183247, the "dpl Faceware" from LED Technologies, cleared March 14, 2019 for wrinkles and acne. It has the same 3-minute treatment and similar light colors, but nothing in FDA's records ties it to Dr. Dennis Gross.
Is the Shark CryoGlow FDA approved?: It is FDA cleared (masks are cleared, not approved). FDA cleared it on November 27, 2024 under K242796, filed by SharkNinja itself. It covers fine lines and wrinkles (red and infrared light) and mild to moderate inflammatory acne (red, blue and infrared light).
Is CurrentBody FDA approved?: It is FDA cleared, not approved. The Series 2 was cleared for full-face wrinkles on June 25, 2025 (K250966). The Series 3 was cleared on June 3, 2026 (K260715): its blue and red mode for acne, its yellow and near-infrared mode for wrinkles, and its red and infrared mode for easing minor muscle and joint pain, not wrinkles.
Is the Solawave LED mask FDA cleared?: Yes, for wrinkles. FDA cleared the "Wrinkle Retreat Pro Light Therapy Face Mask" on December 17, 2025 under K252983. A factory filed it under the product's name; Solawave's name is not on the filing, but Solawave's own site gives this number. It does not cover acne.
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 one already sold, mostly on safety. FDA does not test whether it works. The Omnilux and CurrentBody Series 2 filings both say clinical data was not needed. Approval is a stricter process used for high-risk devices.
How do I check if an LED mask is FDA cleared?: Find the mask's K number (a 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 matches your mask and read the "Indications for Use" line: that is what the clearance covers. If the brand gives no K number, ask for it.

08 / Sources and method

What we checked, and what we did not

FDA 510(k) filings, read October 7, 2026: K242796, K250966, K260715, K191629, K230293, K252983, K241933, K230042, K243492, K233114, and K183247 (dpl Faceware).
FDA device listings (which brand names are registered under each K number), via openFDA, read October 7, 2026.
Amazon prices, sellers and stock: Amazon's product data (Creators API), October 7, 2026. Brand prices from each brand's own store, same day.
Brand pages for Dr. Dennis Gross, Solawave, LightStim, CurrentBody and Omnilux, read October 7, 2026.

What we did not do: we did not test any mask, and we did not ask FDA or the brands. "Tied to" means FDA's filing or listing names the mask or lists its model; we did not confirm that the unit in the box is built the same as the one FDA reviewed. Prices change; check the listing before you buy.