FDA 510(k) Application Details - K191855

Device Classification Name	More FDA Info for this Device
510(K) Number	K191855
Device Name	EmFace Device
Applicant	InMode MD Ltd. Tabor Building, Shaar Yokneam Yoqneam Illit 2069200 IL Other 510(k) Applications for this Company
Contact	Amit Goren 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	07/10/2019
Decision Date	10/29/2019
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