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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
Applicant
Sofwave Medical, Ltd.
Beit Tavor 2
Yokneam,  IL
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  
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
Predetermined Change
Control Plan Authorized		 No
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