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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K163415
FOIA Releasable 510(k) K163415
Device Name SlimShape 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 Number878.4400
Classification Product Code
GEI  
Date Received12/05/2016
Decision Date 04/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02553278
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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