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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 K161952
Device Name UltraShape System
Applicant
Syneron Medical, Ltd.
Tavor Bldg., Industrial Zone, P.O.B. 550
Yokneam Illit,  IL 20692
Applicant Contact Ruthie Amir
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.4590
Classification Product Code
OHV  
Date Received07/15/2016
Decision Date 11/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02465775
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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