Litho PVMS00046
Litho PVMS00046 is a Class II device made by Quanta System SpA, cleared under FDA 510(k) K163009 on 1 Dec 2016 (1 earlier submission) and listed in FDA GUDID since 21 Dec 2016 (UDI-DI 08033945936785), 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 GUDID | Number08033945936785 | Date21 Dec 2016 | StatusListed |
| United States | FDA 510(k) 510(k) | NumberK163009 | Date1 Dec 2016 | StatusActive |
Official records
- AccessGUDID record 08033945936785
- FDA 510(k) database K163009
- FDA 510(k) database K141101
Across registries
- FDA 510(k) K163009 decided 1 Dec 2016 Active
- FDA GUDID UDI-DI 08033945936785 listed 21 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K141101
- Cleared FDA 510(k) K163009
- Listed FDA GUDID 08033945936785
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Litho
- Generic name
- General/multiple surgical solid-state laser system
- Model / reference
- PVMS00046
- Primary DI / UDI-DI
- 08033945936785
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- General/multiple surgical solid-state laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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