FDA 510(k) Application Details - K192295

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K192295
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	Beijing ADSS Development Co., Ltd. 1-2, Jinyuan Road 36, Daxing Economic Development Zone Beijing 102628 CN Other 510(k) Applications for this Company
Contact	Su CuiYing Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2019
Decision Date	05/01/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review