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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name massager, vacuum, radio frequency induced heat
510(k) Number K190743
Device Name Venus Bliss
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
PBX  
Subsequent Product Code
PKT  
Date Received03/22/2019
Decision Date 06/25/2019
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
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