Diode Laser Therapy Machine FG 2000
by Beijing ADSS Development Co., Ltd.
Diode Laser Therapy Machine FG 2000 is a Class II device made by Beijing ADSS Development Co., Ltd., cleared under FDA 510(k) K161692 on 16 Nov 2016 and listed in FDA GUDID since 30 Aug 2022 (UDI-DI 06970453270067), 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 | Number06970453270067 | Date30 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161692 | Date16 Nov 2016 | StatusActive |
Official records
- AccessGUDID record 06970453270067
- FDA 510(k) database K161692
Across registries
- FDA 510(k) K161692 decided 16 Nov 2016 Active
- FDA GUDID UDI-DI 06970453270067 listed 30 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K161692
- Listed FDA GUDID 06970453270067
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diode Laser Therapy Machine
- Generic name
- Dermatological diode laser system
- Model / reference
- FG 2000
- Primary DI / UDI-DI
- 06970453270067
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dermatological diode laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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