InMode RF™ Black-Grey
InMode RF™ Black-Grey (AG606969A) is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K151793 on 19 Feb 2016 and listed in FDA GUDID since 14 Mar 2017 (UDI-DI 07290016633337), 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 | Number07290016633337 | Date14 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151793 | Date19 Feb 2016 | StatusActive |
Official records
- AccessGUDID record 07290016633337
- FDA 510(k) database K151793
Across registries
- FDA 510(k) K151793 decided 19 Feb 2016 Active
- FDA GUDID UDI-DI 07290016633337 listed 14 Mar 2017 Listed
Timeline
- Cleared FDA 510(k) K151793
- Listed FDA GUDID 07290016633337
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- InMode RF™
- Generic name
- Percutaneous radio-frequency ablation system generator
- Model / Ref / Catalog
- InMode RF™ Black-Grey, AG606969A
- Primary DI / UDI-DI
- 07290016633337
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Percutaneous radio-frequency ablation system generator
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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