Fractora AG601260A
Fractora AG601260A (AG601674A) is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K102461 on 2 Jun 2011 and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 17290016633174), 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 | Number17290016633174 | Date25 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102461 | Date2 Jun 2011 | StatusActive |
Official records
- AccessGUDID record 17290016633174
- FDA 510(k) database K102461
Across registries
- FDA 510(k) K102461 decided 2 Jun 2011 Active
- FDA GUDID UDI-DI 17290016633174 listed 25 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K102461
- Listed FDA GUDID 17290016633174
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fractora
- Generic name
- Radio-frequency skin surface treatment system applicator
- Model / Ref / Catalog
- AG601260A, AG601674A
- Primary DI / UDI-DI
- 17290016633174
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Radio-frequency skin surface treatment system applicator
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Dry Heat Sterilization