FDA 510(k) Application Details - K163123

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K163123
Device Name	Powered Laser Surgical Instrument
Applicant	BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. ROOM 305, NO.43, XIZHIMEN NORTH STREET, HAIDIAN DISTRICT BEIJING 100044 CN Other 510(k) Applications for this Company
Contact	HUAN KONG 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	11/08/2016
Decision Date	02/02/2017
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