Titan
by Cutera, Inc.
Titan is a Class II device made by Cutera, Inc., cleared under FDA 510(k) K033768 on 17 Feb 2004 and listed in FDA GUDID since 30 Nov 2022 (UDI-DI 00816722022837), active as of 8 Jun 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 | Number00816722022837 | Date30 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK033768 | Date17 Feb 2004 | StatusActive |
Official records
- AccessGUDID record 00816722022837
- FDA 510(k) database K033768
Across registries
- FDA 510(k) K033768 decided 17 Feb 2004 Active
- FDA GUDID UDI-DI 00816722022837 listed 30 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K033768
- Listed FDA GUDID 00816722022837
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Multi-modality skin contouring system applicator, infrared light
- Model / reference
- Titan
- Primary DI / UDI-DI
- 00816722022837
- 510(k) Number
- FDA product code
- ILY
- GMDN term
- Multi-modality skin contouring system applicator, infrared light
- Device class
- Class II
- Regulation number
- 890.5500
- GUDID distribution status
- In Commercial Distribution
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