The following data is part of a premarket notification filed by Bejing Adss Development Co., Ltd. with the FDA for Pdt-face.
| Device ID | K192295 |
| 510k Number | K192295 |
| Device Name: | PDT-FACE |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Bejing ADSS Development Co., Ltd. 1-2, Jinyuan Road 36, Daxing Economic Development Zone Beijing, CN 102628 |
| Contact | Su Cuiying |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, CN 102401 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-23 |
| Decision Date | 2020-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970453270005 | K192295 | 000 |