FDA 510(k) Application Details - K123435

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K123435
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD 7TH FLOOR 982 CONGYUN ROAD, BAIYUN DISTRICT GUANGZHOU, GUANGDONG 510420 CN Other 510(k) Applications for this Company
Contact	MIKE GU Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2012
Decision Date	02/11/2013
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