FDA 510(k) Application Details - K161043

Device Classification Name	More FDA Info for this Device
510(K) Number	K161043
Device Name	Profound System
Applicant	SYNERON CANDELA CORPORATION 530 BOSTON POST ROAD Wayland, MA 01778 US Other 510(k) Applications for this Company
Contact	Ruthie Amir Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2016
Decision Date	09/12/2016
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