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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 K200786
Device Name Venus Epileve
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 Number878.4810
Classification Product Code
GEX  
Date Received03/26/2020
Decision Date 06/09/2020
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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