Is the FOREO FAQ 202 FDA cleared?

Last reviewed August 2026.

Yes — and the paper has the brand's own name on it. Foreo filed K240378 in its own name in April 2024, naming FAQ 201 and FAQ 202; a second brand-held clearance (K253683) covers the FAQ LED panels. The row is unranked for one reason only: foreo.com geo-serves regional pricing and we could not verify a first-party USD price — no verified price, no rank, the same rule every row gets. The clearance status itself is among the cleanest in the category.

The record on file

Sources — read the record yourself

• FDA 510(k) K240378 — FAQ 201/202, Foreo (2024)
• FOREO — FAQ 202 product page

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.

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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.

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