O35 HH066000
O35 HH066000 is a Class II device made by Hyper Photonics SRL, cleared under FDA 510(k) K163449 on 23 Jun 2017 and listed in FDA GUDID since 9 May 2018 (UDI-DI 08051272100334), 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 | Number08051272100334 | Date9 May 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163449 | Date23 Jun 2017 | StatusActive |
Official records
- AccessGUDID record 08051272100334
- FDA 510(k) database K163449
Across registries
- FDA 510(k) K163449 decided 23 Jun 2017 Active
- FDA GUDID UDI-DI 08051272100334 listed 9 May 2018 Listed
Timeline
- Cleared FDA 510(k) K163449
- Listed FDA GUDID 08051272100334
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- O35
- Generic name
- General/multiple surgical solid-state laser system
- Model / reference
- HH066000
- Primary DI / UDI-DI
- 08051272100334
- 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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