FDA 510(k) Application Details - K162114

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K162114
Device Name	Powered Laser Surgical Instrument
Applicant	Zolar Technology & MFG Co. Inc. 6315 Shawson Drive Mississauga L5T 1J2 CA Other 510(k) Applications for this Company
Contact	Paul Atkins 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	07/29/2016
Decision Date	12/12/2016
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