Pdt-Face
by Beijing ADSS Development Co., Ltd.
510(k) K192295
Pdt-Face is a Class II device made by Beijing ADSS Development Co., Ltd., cleared under FDA 510(k) K192295 on 1 May 2020, 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 | NumberK192295 | Date1 May 2020 | StatusActive |
Official records
- FDA 510(k) database K192295
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLP
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K192295
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 | |||
|---|---|---|---|---|
| Pdt-Face | PDT-FACE | 06970453270005 | — | On the market |
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