FDA 510(k) Application Details - K153568

Device Classification Name	More FDA Info for this Device
510(K) Number	K153568
Device Name	InMode Plus System
Applicant	InMode MD Ltd. Tabor Building, Shaar Yokneam, POB 44 Yoqneam 20692 IL Other 510(k) Applications for this Company
Contact	Ahava Stein 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	12/14/2015
Decision Date	07/12/2016
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