Over-the-counter Powered Light Based Laser For Acne

Bejing ADSS Development Co., Ltd.

The following data is part of a premarket notification filed by Bejing Adss Development Co., Ltd. with the FDA for Pdt-face.

Pre-market Notification Details

Device IDK192295
510k NumberK192295
Device Name:PDT-FACE
ClassificationOver-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
ContactSu Cuiying
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing,  CN 102401
Product CodeOLP  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-23
Decision Date2020-05-01

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