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Faq 101

by Foreo, Inc.

510(k) K222012

Faq 101 is a medical device (FDA Class II; FDA product code PAY, Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction) made by Foreo, Inc., cleared under FDA 510(k) K222012 on 5 Apr 2023, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK222012 Date5 Apr 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PAY
Device class
Class II
Regulation
21 CFR Part 878.4420
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Devices cleared under K222012

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K222012
UDI-DISize and differences
FAQ 101 Amethyst
FOREO INC
Amethyst07640260120037 —On the market

Similar devices

Other devices filed under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).

Other devices from Foreo Inc

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