FDA 510(k) Application Details - K122995

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K122995
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	BEIJING KES BIOLOGY TECHNOLOGY CO., LTD. P.O. BOX 237-023 SHANGHAI 200237 CN Other 510(k) Applications for this Company
Contact	Diana Hong 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	09/26/2012
Decision Date	01/22/2013
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