FDA 510(k) Application Details - K153717

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K153717
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	Venus Concept Ltd. 4556 N. Hiatus Road Sunrise, FL 33351 US Other 510(k) Applications for this Company
Contact	Tal Bresler-Stramer 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	12/24/2015
Decision Date	03/21/2016
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