TattooStar Effect COMBO 1680
by Asclepion Laser Technologies GmbH
TattooStar Effect COMBO 1680 is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Asclepion Laser Technologies GmbH, cleared under FDA 510(k) K131757 on 17 Jul 2014 and listed in FDA GUDID since 14 Nov 2016 (UDI-DI 04058784000064), 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 | Number04058784000064 | Date14 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131757 | Date17 Jul 2014 | StatusActive |
Official records
- AccessGUDID record 04058784000064
- FDA 510(k) database K131757
Across registries
- FDA 510(k) K131757 decided 17 Jul 2014 Active
- FDA GUDID UDI-DI 04058784000064 listed 14 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K131757
- Listed FDA GUDID 04058784000064
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TattooStar Effect COMBO
- Generic name
- Dermatological frequency-doubled solid-state laser system
- Model / reference
- 1680
- Primary DI / UDI-DI
- 04058784000064
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dermatological frequency-doubled solid-state laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Dermatological frequency-doubled solid-state laser system.