FormaI AG609417A
FormaI AG609417A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K210492 on 12 Jul 2021 and listed in FDA GUDID since 5 Jan 2022 (UDI-DI 07290016633658), 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 | Number07290016633658 | Date5 Jan 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210492 | Date12 Jul 2021 | StatusActive |
Official records
- AccessGUDID record 07290016633658
- FDA 510(k) database K210492
Across registries
- FDA 510(k) K210492 decided 12 Jul 2021 Active
- FDA GUDID UDI-DI 07290016633658 listed 5 Jan 2022 Listed
Timeline
- Cleared FDA 510(k) K210492
- Listed FDA GUDID 07290016633658
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- FormaI
- Generic name
- Radio-frequency skin surface treatment system applicator
- Model / reference
- AG609417A
- Primary DI / UDI-DI
- 07290016633658
- 510(k) Number
- FDA product code
- GEI, PBX, ISA, NUV
- GMDN term
- Radio-frequency skin surface treatment system applicator
- Device class
- Class II
- Regulation number
- 878.4400, 890.5660, 878.4810
- GUDID distribution status
- In Commercial Distribution