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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K153717
Device Name Venus Versa System
Applicant
Venus Concept Ltd.
4556 N. Hiatus Road
Sunrise,  FL  33351
Applicant Contact Tal Bresler-Stramer
Correspondent
Hogan Lovells US LLP
1835 Market Street, 29th Floor
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number878.4810
Classification Product Code
ONF  
Subsequent Product Code
GEI  
Date Received12/24/2015
Decision Date 03/21/2016
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
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