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FDA 510(k) Application Details - K230019
Device Classification Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
More FDA Info for this Device
510(K) Number
K230019
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
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
01/03/2023
Decision Date
03/14/2023
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
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