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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K162765
Device Name Venus Velocity Diode Laser System
Applicant
Venus Concept , Ltd.
4556 N. Hiatus Rd.
Sunrise,  FL  33351
Applicant Contact Tal Bresler-Stramer
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/30/2016
Decision Date 01/11/2017
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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