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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 K220592
Device Name Venus BlissMAX
Applicant
Venus Concept USA Inc.
1880 N Commerce Pkwy, Suite 2
Weston,  FL  33326
Applicant Contact William H. McGrail
Correspondent
Venus Concept USA Inc.
1880 N Commerce Pkwy, Suite 2
Weston,  FL  33326
Correspondent Contact William H. McGrail
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Codes
NGX   PKT  
Date Received03/01/2022
Decision Date 04/27/2022
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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