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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 K240687
Device Name SofWave System
Applicant
Sofwave Medical, Ltd.
1 Ha-Otsma St.
Yokneam Iiit,  IL 2069200
Applicant Contact Ruthie Amir
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Hiladelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number878.4590
Classification Product Code
OHV  
Subsequent Product Code
NGX  
Date Received03/12/2024
Decision Date 05/30/2024
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
Predetermined Change
Control Plan Authorized		 No
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