Volnewmer VM1-M120
by CLASSYS Inc.
Volnewmer VM1-M120 is a Class II device made by CLASSYS Inc., cleared under FDA 510(k) K240248 on 29 Apr 2024 and listed in FDA GUDID since 3 Aug 2024 (UDI-DI 08800016902945), 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 | Number08800016902945 | Date3 Aug 2024 | StatusListed |
| United States | FDA 510(k) | NumberK240248 | Date29 Apr 2024 | StatusActive |
Official records
- AccessGUDID record 08800016902945
- FDA 510(k) database K240248
Across registries
- FDA 510(k) K240248 decided 29 Apr 2024 Active
- FDA GUDID UDI-DI 08800016902945 listed 3 Aug 2024 Listed
Timeline
- Cleared FDA 510(k) K240248
- Listed FDA GUDID 08800016902945
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Volnewmer
- Generic name
- Radio-frequency skin/body contouring system
- Model / reference
- VM1-M120
- Primary DI / UDI-DI
- 08800016902945
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Radio-frequency skin/body contouring system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radio-frequency skin/body contouring system.