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 |