Which LED face masks are FDA cleared? Every 510(k) number

Last reviewed October 2026.

We track 18 LED devices. 16 have a 510(k) clearance record in FDA's database. 2 have no record that we could find. We read each record on FDA's own site on 27 October 2026. Each number links to its FDA record.

On Amazon US, the exact listing of each cleared device that Amazon.com or the brand's own store sold, In Stock, at our 9 November 2026 check. The full FDA record of every device follows.

As an Amazon Associate we earn from qualifying purchases, at no extra cost to you — commission never changes a ranking or a verdict (how this site is funded).

Status. “Cleared (brand-held)”: the brand or its parent company is the applicant on the record. “Cleared under an OEM or other name”: the record is real, but it names a manufacturer, a licensor or a different device name. This is legal and common in this category: who holds the paper. “No record found”: the maker or its listing says the device is FDA cleared, but we found no 510(k) record under the names we searched. This is a statement about the public database on the read date, not about the device.

A 510(k) clearance is a safety and equivalence review. It is not a results guarantee and it is not “FDA approval”: cleared, registered and approved. This page lists no prices. Each device page has the full record, the maker's claim and its sources.

Amazon US, 9 November 2026. Each link in the table above opens the exact listing whose buy box we read that day. Amazon offers change, so the listing can differ when you open it. Cleared devices with no link, and why: Omnilux Contour Face: no Omnilux listing on Amazon US is sold by Amazon.com or Omnilux; the untagged search found only a third-party Environ Omnilux Contour listing (B08NCGWVPY); CurrentBody Skin LED Mask Series 2: the featured offer on B0DHRW819R was sold by a third-party seller (Outlet Bed Story), not CurrentBody's own store (read again on 9 November 2026); Solawave Wrinkle Retreat: the Solawave listings sold by SolaWave name the Wrinkle Retreat Pro, not the Wrinkle Retreat, and two of them also sell a neck mask or a serum, so no listing is confirmed as the cleared model (read again on 9 November 2026); HigherDOSE Red Light Face Mask: the listing B09WB6PWCC had no featured offer (See All Buying Options only); The Light Salon Boost: not sold on Amazon US; the untagged search found no Light Salon listing; VogueNow LED Mask: the record covers several models, and the listing names no model; Aphrona MOONLIGHT PRO: the featured offer on B07Z4HDZGW was sold by a third-party seller (Daman USA); Solawave Eye Recovery Pro: the featured offer on B0GQDP4V85 was sold by a third-party seller (Truemarketgoods), not SolaWave (read again on 9 November 2026).

How to check a device yourself

1. Find the K-number. Makers often print it on the box, in the manual or on their website. Open FDA's 510(k) database and type the K-number in the “510(k) Number” field.
2. Read the record. Compare the applicant and the device name with the brand and the model on the box. A different name does not mean a false claim: many brands sell a device that an OEM cleared.
3. No K-number? Search the same database by applicant (the brand or company name) and by device name. LED masks for wrinkles are in product code OHS. LED devices for acne are in product code OLP.
4. Still nothing? Search FDA's registration & listing database for the brand name as “Proprietary Name”. A listing can show which K-number a brand name uses. A registration alone is not a clearance.

The no-record search, 27 October 2026: openFDA 510(k) API, read 2026-10-27: applicant "Dennis Gross" and "DRx" (no results); device name "Dennis Gross" and "EyeCare" (no results); device name "SpectraLite" (one result, K171386 dpl SpectraLite, LED Technologies, Inc.); device name "Faceware" (one result, K183247 dpl Faceware, LED Technologies, Inc.). openFDA registration & listing API: proprietary names "Dennis Gross", "SpectraLite" and "Faceware" (no results); proprietary name "EyeCare" (one result, "Eyecare", ICU Eyecare Solutions Inc., product code HOI (magnifying spectacles), not a light-therapy device).

The best LED face mask, ranked by measured irradiance › · every mask, claim by claim › · LED eye devices ›

LED Mask Score indexes manufacturers' FDA marketing claims against the FDA's own public record — the 510(k) database and the registration & listing index — with links, so you can read the paper yourself. We test nothing and give no medical or skincare advice. A 510(k) clearance is a safety-and-equivalence review, not a performance ranking, an endorsement, or an "FDA approval." If a brand publishes a K-number or listing that changes a row, the page changes — the record wins.

Some product links on this page are affiliate links: as an Amazon Associate we earn from qualifying purchases, at no extra cost to you. Affiliate status never changes a ranking or a verdict — full affiliate disclosure.

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