FDA 510(k) Application Details - K231537

Device Classification Name	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption   More FDA Info for this Device
510(K) Number	K231537
Device Name	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Applicant	Sofwave Medical Ltd. 1 Ha-Otsma St. Yokneam Ilit 2069200 IL Other 510(k) Applications for this Company
Contact	Ruthie Amir, MD 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	05/30/2023
Decision Date	08/28/2023
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