FDA 510(k) Application Details - K242598

Device Classification Name	More FDA Info for this Device
510(K) Number	K242598
Device Name	DEFINE System (AG612444A)
Applicant	InMode Ltd. Tabor Building, Shaar Yokneam Yokneam 2069200 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	08/30/2024
Decision Date	11/14/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review