The box says FDA cleared. The record says whose paper it is.
Every LED face mask is sold on the same two words — FDA cleared. The FDA's own databases say what that means for each mask: the K-number, the year, the cleared indication, and the holder — which for much of this category is an OEM or licensor, not the brand on the box. We match every claim to that record, link the paper, and call out the claims we couldn't match at all. We publish no medical advice — we index the claims and the record.
What we index
Four facts per mask — the claim as printed, and the record that says what's actually behind it.
Every real “FDA cleared” is a 510(k) with a public K-number and record page. We link it on every row. A claim with no matchable K-number is called out, not ranked.
Whose paper is it? Much of the category rides clearances held by OEMs and licensors — Shenzhen Kaiyan, Light Tree Ventures, the iSMART constellation — not the brand on the box. Legal, common, and worth knowing.
A 510(k) clears an indication — wrinkles (code OHS), acne (OLP), or both. Some listings sell more indications than their matched record covers; those rows say so.
A verified first-party USD price with its source and date — no price on record, no rank. The dataset never guesses a number.
Every matched claim, priced
Showing … masks with an FDA claim matched to a real K-number and a verified first-party price · sorted by price · last reviewed 2026-07
| # | Mask | Price | K-number | Whose K | Cleared for |
|---|
K-number links the FDA’s own record page for the clearance the mask’s claim rides — including the device name in the record, which is not always the name on the box. “FDA cleared” is a 510(k) safety-and-equivalence review, not a performance ranking and not “FDA approval.” No matched K-number, no rank; no verified first-party price, no rank. Prices drift; the linked listing is authoritative, and each row records its price source and date in the dataset. Some product links are affiliate links — if you buy through them we may earn a commission, at no cost to you. Links appear only on rows whose claim matched a real K-number — never on the below-the-line rows — and they never change the order.
In the record, unranked
Below the line — claims we couldn’t match to the record
Some masks print “FDA Cleared” where no K-number under any name we checked surfaces in the FDA’s public databases — and some Amazon listings ride real clearances while never stating which model you’d receive, or claim more indications than the matched record covers. These rows are kept out of the ranking entirely and carry no purchase links — each card links the full sourced answer. Absence from the index is a statement about the index on the check date, not an accusation; if a brand publishes its paper, the row moves the same day.
Why this table is different
“Registered” is not “cleared”
“FDA registered” means a factory is on a list — no device review at all. “FDA approved” doesn’t exist for LED masks. One phrase means a review happened, and it comes with a number you can look up. The three phrases, decoded →
The $395 mask and the marketing company’s K
The best-known mask in the category is listed under a 2019 clearance for a device named “faceLITE,” held by a UK marketing firm — one listing carries nineteen brand names. Whose paper the category rides →
Cleared ≠ consequence-free
Neutrogena’s mask was 510(k)-cleared — and voluntarily recalled in 2019 over theoretical eye risk. Adverse-event reports exist for cleared masks sold today. The record, not our opinion. The eye-safety record →
Mask by mask
The question everyone asks, answered from the record.