ATL Angelite-SDC
by Advanced Technology Laser Co., Ltd.
ATL Angelite-SDC is a Class II device made by Advanced Technology Laser Co., Ltd., cleared under FDA 510(k) K083915 on 29 Jan 2009 and listed in FDA GUDID since 20 Oct 2016 (UDI-DI 06970507240015), 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 | Number06970507240015 | Date20 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083915 | Date29 Jan 2009 | StatusActive |
Official records
- AccessGUDID record 06970507240015
- FDA 510(k) database K083915
Across registries
- FDA 510(k) K083915 decided 29 Jan 2009 Active
- FDA GUDID UDI-DI 06970507240015 listed 20 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K083915
- Listed FDA GUDID 06970507240015
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Atl
- Generic name
- Intense pulsed light skin surface treatment system
- Model / reference
- Angelite-SDC
- Primary DI / UDI-DI
- 06970507240015
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Intense pulsed light skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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