FOREO
FAQ 101
FDA cleared · K222012
“Cleared” means the FDA found the device substantially equivalent to one already legally sold, for a stated use. It isn’t proof it works for you. What clearance means
What it’s cleared for
Its clearance is under FDA product code PAY (“Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction”). We haven’t extracted the exact indications-for-use text from its filing yet.
Who should skip it
We haven’t sourced category-specific cautions yet. Read the maker’s directions.
The FDA record
Yes — the FDA record names FOREO FAQ 101.
K222012 · View FDA record
- Device name in the FDA record
- FAQ 101
- Applicant
- Foreo, Inc.
- Decision date
- 2023-04-05
- Product code
- PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
- Evidence
- FDA record names this model; retail model variants are not inferred. openFDA source; retrieved 2026-10-19.
Specifications
- Treatment areas (see source for restrictions)
- face, neck · Source — not yet human-reviewed · retrieved 2026-10-19
Excludes midline/thyroid neck and orbital eye area. - Coded cautions (read full instructions)
- metal-implant, epilepsy · Source — not yet human-reviewed · retrieved 2026-10-19
Codes summarize sourced contraindications and warnings only; consult complete manual for additional restrictions. Each mapped code has its own verbatim supporting quote. - Cordless
- Yes · Source — not yet human-reviewed · retrieved 2026-10-19
- App required
- Yes · Source — not yet human-reviewed · retrieved 2026-10-19
App mandatory for first activation; later basic manual use possible. - Warranty (years)
- 2 · Source — not yet human-reviewed · retrieved 2026-10-19
Standard US warranty; registration and policy conditions apply. FAQ 101 manufacturer manual separately states two-year limited warranty. - Return window (days; conditions apply)
- 14 · Source — not yet human-reviewed · retrieved 2026-10-19
Unopened purchases from FOREO; opened products excluded.
Technical details appear only after we’ve checked and cited a source.
Price
USD 390.0 · Source · retrieved 2026-10-20
We verify region, currency, and source date before listing a price.
Where to buy
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