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The Tracker / October 2026 / K261565

510(k) cleared

FAQ (FAQ 411)

Foreo, Inc. · Oct 22, 2026 · K261565

FDA cleared the FAQ (FAQ 411) from Foreo, Inc. on Oct 22, 2026 under K261565, a traditional 510(k). The device falls under product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes, regulated at 21 CFR 882.5890 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 11, 2026. The decision came 164 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Foreo, Inc. has one other decision in the tracker over the last 12 months: K253683 (FAQ (LED Panel); FAQ (Dual LED Panel)).

Questions & Answers

What did FDA clear under K261565?

K261565 is the FDA 510(k) for FAQ (FAQ 411), submitted by Foreo, Inc.. FDA's decision date was Oct 22, 2026, under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Who makes the FAQ (FAQ 411)?

Foreo, Inc., based in Las Vegas, NV, is the applicant of record for K261565.

How long did the K261565 review take?

FDA received the submission on May 11, 2026 and issued its decision on Oct 22, 2026, 164 days later.

← All decisions in October 2026

Sources