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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name focused ultrasound for tissue heat or mechanical cellular disruption
510(k) Number K191421
Device Name Sofacia System
Sofwave Medical Ltd.
Beit Tavor 2
Yokneam,  IL
Applicant Contact Ruthie Amir
Hogan Lovells US LLP
1735 Market Street, Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number878.4590
Classification Product Code
Date Received05/28/2019
Decision Date 09/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No