FDA 510(k) Application Details - K160549

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K160549
Device Name	Powered Laser Surgical Instrument
Applicant	WUHAN GIGAA OPTRONICS TECHNOLOGY CO., LTD 5, 6/F, UNIT A, B, BUILDING B8, HI-TECH MEDICAL DEVICE INDUSTRIAL PARK, #818 GAOXIN AVENUE EAST LAKE DEVELOPMENT ZONE, WUHAN 430206 CN Other 510(k) Applications for this Company
Contact	NIE XINXING 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	02/29/2016
Decision Date	04/07/2017
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