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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 K213308
Device Name Venus BlissMAX
Applicant
Venus Concept USA, Inc.
1880 N Commerce Pkwy.,
Suite 2
Weston,  FL  33326
Applicant Contact Nadav Reuben
Correspondent
Venus Concept USA, Inc.
1880 N Commerce Pkwy.,
Suite 2
Weston,  FL  33326
Correspondent Contact Nadav Reuben
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Codes
NGX   PKT  
Date Received10/04/2021
Decision Date 01/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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