FDA 510(k) Application Details - K131837

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K131837
Device Name	Powered Laser Surgical Instrument
Applicant	BEIJING HONKON TECHNOLOGIES CO., LTD 7TH FL. JINGGUI BUSINESS BLDG NO. 982 CONGYUM RD, BAIUN 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	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2013
Decision Date	01/22/2014
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