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 clearance status itself is among the cleanest in the category. foreo.com geo-serves regional pricing, so we could not verify a first-party US offer; FOREO's own FAQ 202 listing on Amazon US (B0DPQYHJH7, sold by FOREO) was read on 2026-10-03 and is the row's recorded US offer. The mask has no measurement under the cited protocol, so the irradiance ranking lists it as waiting.
The record on file
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| Verdict | Brand-held K — Cleared — the brand holds its own K-number |
| K-number | K240378 · decided 2024-04-19 · device name “FAQ 201, FAQ 202” |
| Holder | Foreo, Inc. |
| Cleared for | Wrinkles (OHS) · acne per OLP listing |
| Wavelengths | 8 published wavelengths incl. 650 nm red · 850 nm NIR · 465 nm blue |
| The claim | “No FDA language found on the official product page we could reach (geo-served); the clearance itself is real and brand-held” (foreo.com (checked 2026-07-16)) FOREO ↗ Amazon ↗ |
Sources — read the record yourself
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.
Comparing FOREO devices? FOREO LUNA 4 vs LUNA 4 go and using the LUNA 4 without the app are on BeautyEvidence.
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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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