FDA 510(k) Application Details - K191421

Device Classification Name	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption   More FDA Info for this Device
510(K) Number	K191421
Device Name	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Applicant	Sofwave Medical Ltd. Beit Tavor 2 Yokneam IL Other 510(k) Applications for this Company
Contact	Ruthie Amir Other 510(k) Applications for this Contact
Regulation Number	878.4590   More FDA Info for this Regulation Number
Classification Product Code	OHV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2019
Decision Date	09/09/2019
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