FDA-Cleared LED Face Masks: The Verified List With 510(k) Numbers

The short answer

Shopping for the best mask rather than a list? Our ranked guide is the best red light therapy and LED face masks. New to FDA labels? Read FDA cleared vs approved vs registered.

The verified list: FDA-cleared LED face masks

Device names are as written in FDA’s records (trademark symbols removed). “Applicant match” means the brand name isn’t in FDA’s record but the applicant or model numbers match the brand’s other cleared mask. Download the list: CSV (free to reuse with a link to this page).

Best FDA-cleared LED face masks

From the verified list, these are the masks we’d look at first, based on published wavelengths, coverage, extras and price. Full write-ups are in our LED mask guide.

Prices from each brand’s US site: CurrentBody, Shark, Solawave and Therabody checked October 7, 2026; Ulike October 8, 2026.

• Best FDA-cleared LED mask for wrinkles overall: CurrentBody Series 2, for its red, near-infrared and deep near-infrared wavelengths at a mid-range price.
• Best value: Shark CryoGlow.
• Fastest sessions: Solawave Wrinkle Retreat Pro (3 minutes).
• Wrinkles and acne in one cleared mask: Ulike ReGlow or FOREO FAQ 202, both with acne listed in FDA’s letters.

Popular masks we couldn’t match to a 510(k)

• Omnilux Contour Face. Omnilux says it’s FDA-cleared. FDA lists several Omnilux clearances (for example Omnilux CLEAR, K210948, an acne mask, and older Omnilux devices from Photo Therapeutics), but we found none under the Contour name.
• Dr. Dennis Gross DRx SpectraLite FaceWare Pro. The brand says it’s FDA-cleared. We found no clearance under Dr. Dennis Gross. LED Technologies, Inc. holds clearances for “dpl SpectraLite” (K171386) and “dpl Faceware” (K183247), which share naming with the DDG mask, but we couldn’t confirm they cover it.
• Searched with no 510(k) found under the brand name: Qure, Joovv, Hooga, Angela Caglia and Mito Red Light (as of October 8, 2026). Some devices are cleared under a manufacturer’s name, so this doesn’t prove a mask isn’t cleared. Ask the brand for its K-number.

FDA-cleared LED devices that aren’t masks

Some cleared home LED devices aren’t face masks, which matters if you want hands-free use: the Jmoon FlexGlow (K251825, cleared October 1, 2025) is a mirrored tabletop device per its 510(k) summary, and the Dermalux Flex MD (K212275, November 18, 2021) is a flexible LED panel that sits in a base for facial treatments.

What “FDA-cleared” means for an LED mask

Over-the-counter LED wrinkle and acne devices are Class II medical devices under 21 CFR 878.4810. To sell one, a company submits a 510(k) premarket notification showing the device is substantially equivalent to one already legally marketed. When FDA agrees, the device is “cleared” and gets a K-number. That is different from:

• FDA-approved: the premarket approval (PMA) route for higher-risk devices. LED masks don’t use it.
• FDA-registered or listed: the company has registered its facility and listed the device. FDA says registration “does not in any way denote approval” (21 CFR 807.39). A mask that is only “registered” hasn’t been cleared.

Clearance isn’t a measure of how well a mask works. The evidence for red and near-infrared light comes from research such as a 2025 randomized, double-blind, sham-controlled trial in which a home 630/850 nm mask improved crow’s feet versus sham over 16 weeks (Park 2025), and an earlier controlled trial of red and near-infrared light (Wunsch 2014). For acne, a Cochrane review rated the evidence for light therapies as low quality (Barbaric 2016).

How to check any LED mask yourself

1. Find the K-number on the box, manual or brand FAQ, or ask customer service. A real one looks like “K250966”.
2. Open FDA’s 510(k) Premarket Notification database and enter it in the “510(k) Number” field.
3. Check the device name, applicant and model numbers against the mask you’re buying. The applicant may be the factory rather than the brand.
4. Check the product code: OHS (wrinkles) or OLP (acne). Open the “Summary” or “Statement” PDF for the indications for use.
5. If a brand only says “FDA registered” or won’t give a K-number, treat “FDA-cleared” as unverified.

How we built this list

We queried FDA’s 510(k) dataset through openFDA for product codes OHS and OLP, and searched by the brand and device names of LED masks sold to US shoppers. We kept clearances for full-face, at-home LED masks and checked each record’s name, date, applicant and code. Then we re-checked every K-number on October 8, 2026. If a mask you own is missing, email us its K-number via our contact page and we’ll add it once we’ve verified it.