Venus BlissMAX

Massager, Vacuum, Radio Frequency Induced Heat

Venus Concept USA Inc.

The following data is part of a premarket notification filed by Venus Concept Usa Inc. with the FDA for Venus Blissmax.

Pre-market Notification Details

Device IDK220592
510k NumberK220592
Device Name:Venus BlissMAX
ClassificationMassager, Vacuum, Radio Frequency Induced Heat
Applicant Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston,  FL  33326
ContactWilliam H. Mcgrail
CorrespondentWilliam H. Mcgrail
Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston,  FL  33326
Product CodePBX  
Subsequent Product CodeNGX
Subsequent Product CodePKT
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-01
Decision Date2022-04-27

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