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FDA 510(k) Application Details - K211483
Device Classification Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
More FDA Info for this Device
510(K) Number
K211483
Device Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Applicant
Sofwave Medical Ltd.
Beit Tavor 2
Yokneam Ilit 2069202 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
05/12/2021
Decision Date
11/15/2021
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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