FDA-cleared LED face masks on Amazon
6 masks matched to their own 510(k) in the FDA database by the name or model number on the listing: the K-number, what the FDA cleared each for, the wavelengths its summary states, and today's price, cheapest first.
UlikeRed Light Therapy Mask
510(k) K260511, cleared for full-face wrinkles and mild to moderate inflammatory acne.
Light: 465, 590, 630, 830 nm. Sold by Ulike Official US.
$219
HigherDOSERed Light Face Mask
510(k) K241933, cleared for full-face wrinkles.
Light: 630, 830 nm. Sold by FRONT ROW.
$269.99
SharkCryoGlow LED Face Mask
510(k) K242796, cleared for full-face wrinkles and mild to moderate acne.
Light: 415, 633, 830 nm. Sold by Amazon.com.
$299
CurrentBodySkin LED Light Therapy Mask Series 2
510(k) K250966, cleared for full-face wrinkles.
Light: 633, 830 nm. Sold by The Beauty Tech Group Ltd.
$469.99
FOREOFAQ 202 Advanced 8-Color LED Face Mask
510(k) K240378, cleared for wrinkles and mild to moderate acne.
Wavelengths: not stated in the 510(k) summary. Sold by FOREO.
$499
TherabodyTheraFace Mask
510(k) K230293, cleared for full-face wrinkles and acne.
Light: 415, 633, 830 nm. Sold by TheraGun.
$559.99
Sold as FDA-cleared, not found under their own name
These listings say FDA-cleared, and we found no 510(k) under the brand or the model number. That isn't proof they aren't cleared: a clearance often sits under the name of the factory that makes the mask. Ask the seller for the K-number and look it up.
- Nanoleaf LED Light Therapy Face Mask (model NLEDK00-1TFM)No 510(k) under Nanoleaf or the model number.
- RENPHO Red Light Therapy Mask (model E100B)No 510(k) under RENPHO or the model number.
- wavytalk Red Light Therapy Mask (model E106A)No 510(k) under wavytalk or the model number.
- iRestore Red Light Therapy face maskiRestore's 510(k)s on record are all for hair growth devices.
- INIA Red Light Therapy MaskINIA's 510(k)s, K253833 and K252553, cover a handheld facial and body device, cleared for wrinkles around the eyes, not a full-face mask.
- Dr. Dennis Gross DRx SpectraLite FaceWare ProThe SpectraLite entry, K171386 (dpl SpectraLite, LED Technologies, 2017), is cleared for wrinkles around the eyes.
- Omnilux Contour FaceNo entry under the Contour name; the Omnilux clearance for wrinkles on record is Omnilux New-U, K072459, from 2008.
Questions
Which LED face masks on Amazon are FDA-cleared?
6 that we matched to their own 510(k): Ulike Red Light Therapy Mask (K260511), HigherDOSE Red Light Face Mask (K241933), Shark CryoGlow (K242796), CurrentBody LED Mask Series 2 (K250966), FOREO FAQ 202 (K240378), Therabody TheraFace Mask (K230293). Each record names what the mask is cleared for; some are cleared for wrinkles only, some for acne as well.
What is the cheapest FDA-cleared LED face mask on Amazon?
Of the masks we matched to a 510(k), the Ulike Red Light Therapy Mask, at $219 on Amazon today, cleared under K260511 for full-face wrinkles and mild to moderate inflammatory acne.
Is FDA-cleared the same as FDA-approved?
No. LED masks reach the market through the FDA's 510(k) route: the FDA finds a device substantially equivalent to one already sold, for the use it names, and clears it. Approval is a separate, stricter review the FDA keeps for higher-risk devices. A mask sold as "FDA-approved" is, at most, cleared.
What wavelengths do FDA-cleared LED masks use?
Across the 6 here, red light at 630 to 633 nm and near-infrared at 830 nm for wrinkles; the ones also cleared for acne add blue at 415 to 465 nm. FOREO's summary doesn't state its wavelengths.
How do I check whether an LED mask is FDA-cleared?
Search the FDA's 510(k) database by the brand, by the model number on the listing, or by the K-number the seller gives. The record names the company that filed it, which is often the factory rather than the brand: Shenzhen Kaiyan Medical filed for both CurrentBody's Series 2 and HigherDOSE's mask.