The following data is part of a premarket notification filed by Bejing Adss Development Co., Ltd. with the FDA for 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|
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, CN 102401
|CFR Regulation Number||878.4810 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|