Venus Viva MD Device

Electrosurgical, Cutting & Coagulation & Accessories

Venus Concept USA Inc.

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

Pre-market Notification Details

Device IDK201164
510k NumberK201164
Device Name:Venus Viva MD Device
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston,  FL  33326
ContactYoni Iger
CorrespondentYoni Iger
Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston,  FL  33326
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-01
Decision Date2020-06-26

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