FAQ 101 Amethyst
by Foreo Inc
FAQ 101 Amethyst is a multi-modality skin/body contouring system (FDA Class II) made by Foreo Inc, cleared under FDA 510(k) K222012 on 5 Apr 2023 and listed in FDA GUDID since 1 Mar 2024 (UDI-DI 07640260120037), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07640260120037 | Date1 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222012 | Date5 Apr 2023 | StatusActive |
Official records
- AccessGUDID record 07640260120037
- FDA 510(k) database K222012
Across registries
- FDA 510(k) K222012 decided 5 Apr 2023 Active
- FDA GUDID UDI-DI 07640260120037 listed 1 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K222012
- Listed FDA GUDID 07640260120037
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Faq 101
- Generic name
- Multi-modality skin/body contouring system
- Model / reference
- Amethyst
- Primary DI / UDI-DI
- 07640260120037
- 510(k) Number
- FDA product code
- PAY, OHS
- GMDN term
- Multi-modality skin/body contouring system
- Device class
- Class II
- Regulation number
- 878.4420, 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).