Studio PNMS00181
Studio PNMS00181 is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Quanta System SpA, cleared under FDA 510(k) K103539 on 20 Jan 2011 and listed in FDA GUDID since 18 Aug 2016 (UDI-DI 08033945934224), 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 | Number08033945934224 | Date18 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103539 | Date20 Jan 2011 | StatusActive |
Official records
- AccessGUDID record 08033945934224
- FDA 510(k) database K103539
Across registries
- FDA 510(k) K103539 decided 20 Jan 2011 Active
- FDA GUDID UDI-DI 08033945934224 listed 18 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K103539
- Listed FDA GUDID 08033945934224
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Studio
- Generic name
- Dermatological frequency-doubled solid-state laser system
- Model / reference
- PNMS00181
- Primary DI / UDI-DI
- 08033945934224
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dermatological frequency-doubled solid-state laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Dermatological frequency-doubled solid-state laser system.