Twain Evo OAM002011
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Overview
A comprehensive 2-3 paragraph SEO description written in clear, natural language. The device is a skin surface treatment system that conducts one or more generated light energies for ablative and non-ablative treatment of various skin conditions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08059173390076 | Date14 Dec 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160368 | Date5 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 08059173390076
- FDA 510(k) database K160368
Across registries
- FDA 510(k) K160368 decided 5 Apr 2016 Active
- FDA GUDID UDI-DI 08059173390076 listed 14 Dec 2018 Listed
Timeline
- Cleared FDA 510(k) K160368
- Listed FDA GUDID 08059173390076
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Twain Evo
- Generic name
- Light-energy skin surface treatment system applicator
- Model / reference
- OAM002011
- Primary DI / UDI-DI
- 08059173390076
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Light-energy skin surface treatment system applicator
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Light-energy skin surface treatment system applicator.