FDA-cleared LED face masks: 510(k) numbers checked
21 of the 27 LED masks we track are FDA cleared, each with a K number linked to its record. 19 share one product code, OHS (wrinkle reduction), so clearance is a floor, not a ranking. Cheapest cleared mask: Solawave Radiant Renewal Eye Recovery Pro (PH-e03) at $249.
K numbers open the FDA record and its summary PDF. "Filed by" is the 510(k) applicant, often not the brand on the box. Prices from brand sites, checked Oct 8, 2026. All red light devices in the FDA database.
Who actually filed each clearance
The brand on the box is often not the company in the FDA record. Of the 21 cleared masks, 4 were filed by Shenzhen Kaiyan Medical Equipment and 3 by Light Tree Ventures Europe. Shark, Therabody and FOREO filed their own. When a factory files, the record names the factory's model number, and it's the brand's word that the mask you buy is that model.
Bon Charge describes its mask only as "FDA Registered", yet the FDA listing links it to K221775, a 2022 clearance by Light Tree Ventures Europe. The brand undersells it. The reverse, a brand saying "cleared" with no record to back it, is the case to watch: that's Dr. Dennis Gross and Hooga in the table above.
Questions people ask
Is the Omnilux face mask FDA cleared?
Yes. The Omnilux Contour Face is covered by K191629, decided Sep 12, 2019. The FDA record names the device "faceLITE." More in the Omnilux review.
Which LED face mask is FDA-cleared?
21 masks in our database, all listed in the table with K numbers: from the Solawave Radiant Renewal Eye Recovery Pro (PH-e03) ($249) up. 19 of them are cleared for wrinkles under code OHS alone; the rest carry the acne code OLP, instead of OHS for the Omnilux Clear and next to OHS for the Celluma MYSTIQUE LED Mask.
Is there an LED mask the FDA has approved?
No. LED masks are Class II devices and get a 510(k) clearance; "approval" is for Class III devices. When a brand says "approved," read it as "cleared" and check the K number.
Which is better, Omnilux or Shark?
Both are cleared: Omnilux under K191629, the Shark CryoGlow LED Face Mask (FW312) under K242796. Shark adds under-eye cooling and costs $299.99; Omnilux costs $395 and publishes its wavelengths (633 and 830 nm). Details in the Shark CryoGlow review and the Omnilux review.