Xtrac AL10000 V400
Xtrac AL10000 V400 is a dermatological excimer laser system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by STRATA Skin Sciences, Inc, cleared under FDA 510(k) K073659 on 5 Mar 2008 and listed in FDA GUDID since 13 Feb 2017 (UDI-DI 011000002), active as of 22 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 | Number011000002 | Date13 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK073659 | Date5 Mar 2008 | StatusActive |
Official records
- AccessGUDID record 011000002
- FDA 510(k) database K073659
Across registries
- FDA 510(k) K073659 decided 5 Mar 2008 Active
- FDA GUDID UDI-DI 011000002 listed 13 Feb 2017 Listed
Timeline
- Cleared FDA 510(k) K073659
- Listed FDA GUDID 011000002
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Xtrac
- Generic name
- Dermatological excimer laser system
- Model / reference
- AL10000 V400
- Primary DI / UDI-DI
- 011000002
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dermatological excimer laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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