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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 K191528
Device Name Venus Legacy Pro Device
Applicant
Venus Concept USA, Inc.
1880 N Commerce Pkwy.,
Suite 2
Weston,  FL  33326
Applicant Contact Yoni Iger
Correspondent
Biovision , Ltd.
Had Nes 183
Had Nes,  IL 1295000
Correspondent Contact Elissa Burg
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
PBX  
Date Received06/10/2019
Decision Date 09/06/2019
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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