Solera Opus
by Cutera, Inc.
Solera Opus is a Class II device made by Cutera, Inc., cleared under FDA 510(k) K050679 on 31 Mar 2005 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816722021908), active as of 21 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 | Number00816722021908 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050679 | Date31 Mar 2005 | StatusActive |
Official records
- AccessGUDID record 00816722021908
- FDA 510(k) database K050679
Across registries
- FDA 510(k) K050679 decided 31 Mar 2005 Active
- FDA GUDID UDI-DI 00816722021908 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K050679
- Listed FDA GUDID 00816722021908
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Multi-modality skin surface treatment system
- Model / reference
- Solera Opus
- Primary DI / UDI-DI
- 00816722021908
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Multi-modality skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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