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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 K160896
Device Name ULTRASHAPE POWER SYSTEM
Applicant
SYNERON MEDICAL LTD
TAVOR BUILDING, INDUSTRIAL ZONE, P.O.B.550
Yokneam Illit,  IL 20692
Applicant Contact Ruthie Amir
Correspondent
Hogan Lovells US LLP
1835 Market Street, 29th Floor
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.4590
Classification Product Code
OHV  
Date Received03/31/2016
Decision Date 07/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02154113
Reviewed by Third Party No
Combination Product No
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