DenaVe PDMS00253
DenaVe PDMS00253 is a Class II device made by Quanta System SpA, cleared under FDA 510(k) K172198 on 17 Oct 2017 and listed in FDA GUDID since 8 Jun 2018 (UDI-DI 08033945938857), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number08033945938857 | Date8 Jun 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172198 | Date17 Oct 2017 | StatusActive |
Official records
- AccessGUDID record 08033945938857
- FDA 510(k) database K172198
Across registries
- FDA 510(k) K172198 decided 17 Oct 2017 Active
- FDA GUDID UDI-DI 08033945938857 listed 8 Jun 2018 Listed
Timeline
- Cleared FDA 510(k) K172198
- Listed FDA GUDID 08033945938857
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DenaVe
- Generic name
- Dermatological solid-state laser system
- Model / reference
- PDMS00253
- Primary DI / UDI-DI
- 08033945938857
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dermatological solid-state laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- Not in Commercial Distribution
Similar devices in this category
Other devices filed under Dermatological solid-state laser system.