FDA 510(k) Application Details - K161926

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K161926
Device Name	Powered Laser Surgical Instrument
Applicant	Beijing ADSS Development Co., Ltd F6, Xiandao Bldg., Jinyuan Rd. 36 Daxing Economic Development zone Beijing 102628 CN Other 510(k) Applications for this Company
Contact	Gao Yurong Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2016
Decision Date	02/22/2017
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