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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 K232455
Device Name SofWave System
Applicant
Sofwave Medical Ltd.
1 Ha-Otsma St.
Yokneam Ilit,  IL 2069200
Applicant Contact Ruthie Amir
Correspondent
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.4590
Classification Product Code
OHV  
Subsequent Product Code
NGX  
Date Received08/14/2023
Decision Date 12/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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