Is the Aphrona MOONLIGHT PRO FDA cleared?

Last reviewed July 2026.

Yes — the clearance is real. It just isn't held by the name on the box. FDA's listing index maps “Aphrona LED facial mask” to K192295 — a May 2020 acne-code (OLP) clearance held by Beijing ADSS Development for a device named PDT-FACE. The Amazon title sells both “Acne Removal” and “Wrinkle Reduction”; the matched record covers the first. A wrinkle-code clearance may exist under another name — the index is searchable and we say only what it showed on the check date. Until a wrinkle-code record is matched, the title claims more indications than the paper we can find: the cleanest example in the table of an indication-scope gap, which is a different failure mode than a fake claim.

The record on file

Sources — read the record yourself

• FDA 510(k) K192295 — PDT-FACE, Beijing ADSS Development (2020, acne/OLP)
• Amazon — Aphrona MOONLIGHT PRO listing (claim in title)

How to read this

“FDA cleared” means a 510(k): the FDA reviewed the device as substantially equivalent to one already on the market and assigned a K-number you can look up. It is not “FDA approved” (a drug/high-risk standard no LED mask meets), and it is nothing like “FDA registered,” which only means a factory is on a list — the three phrases, decoded. Many real clearances are held by OEMs and licensors rather than the brand on the box — who actually holds the category's paper. A clearance is a safety review, not a results guarantee, and adverse-event reports exist for cleared masks — the eye-safety record.

See every mask we track, claim by claim → · the claims we couldn't match →

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.