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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 K142910
Device Name Legacy BX
Applicant
Venus Concept USA, Inc.
4556 N. Hiatus Rd.
Sunrise,  FL  33351
Applicant Contact Lilia Schlosberg
Correspondent
A. Stein - Regulatory Affairs Consulting , Ltd.
175 Derby St.,
Unit 27, Suite 1
Hingham,  MA  02043
Correspondent Contact Ahava Stein
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/06/2014
Decision Date 12/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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