Crystal 512
Crystal 512 is a multi-modality skin surface treatment system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Active Optical Systems Ltd, cleared under FDA 510(k) K050950 on 29 Apr 2005 and listed in FDA GUDID since 29 Jan 2018 (UDI-DI 07290016727081), 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 | Number07290016727081 | Date29 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050950 | Date29 Apr 2005 | StatusActive |
Official records
- AccessGUDID record 07290016727081
- FDA 510(k) database K050950
Across registries
- FDA 510(k) K050950 decided 29 Apr 2005 Active
- FDA GUDID UDI-DI 07290016727081 listed 29 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K050950
- Listed FDA GUDID 07290016727081
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Crystal
- Generic name
- Multi-modality skin surface treatment system
- Model / reference
- 512
- Primary DI / UDI-DI
- 07290016727081
- 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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