Diode Laser Therapy Machine
by Beijing ADSS Development Co., Ltd.
510(k) K161692
Diode Laser Therapy Machine is a Class II device made by Beijing ADSS Development Co., Ltd., cleared under FDA 510(k) K161692 on 16 Nov 2016, 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 | FDA 510(k)SESE | NumberK161692 | Date16 Nov 2016 | StatusActive |
Official records
- FDA 510(k) database K161692
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K161692
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Diode Laser Therapy Machine FG 2000 | FG 2000 | 06970453270067 | — | On the market |
| Diode Laser Therapy Machine FG 2000-B | FG 2000-B | 06970453270074 | — | On the market |
| Diode Laser Therapy Machine FG 2000-C | FG 2000-C | 06970453270081 | — | On the market |
| Diode Laser Therapy Machine FG 2000-D | FG 2000-D | 06970453270098 | — | On the market |
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