Venus VivaTM
K-Number: K191065 · 2020-04-01
ApplicantVenus Concept USA, Inc.
Decision Date2020-04-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Venus VivaTM is a medical device manufactured by Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2020-04-01 under approval number K191065. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Venus VivaTM?
Venus VivaTM is a medical device that received FDA 510(k) clearance on 2020-04-01. It is manufactured by Venus Concept USA, Inc.. The 510(k) number is K191065.
When was Venus VivaTM approved by the FDA?
Venus VivaTM received FDA 510(k) clearance on 2020-04-01, under approval number K191065.
What company makes Venus VivaTM?
Venus VivaTM is manufactured by Venus Concept USA, Inc..
What is the FDA product code for Venus VivaTM?
The FDA product code for Venus VivaTM is GEI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.