FAQ 101

Foreo AB · Model Amethyst · UDI-DI 07640260120037

510(k) clearances

Adverse events

Recalls

Facilities

Description

FAQ™ 101 device is an over-the-counter home use devices intended for non-invasive treatments of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.