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FDA 510(k)

Venus Viva MD Device

K-Number: K201164 · 2020-06-26

Decision Date2020-06-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venus Viva MD Device is a medical device manufactured by Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2020-06-26 under approval number K201164. 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 Viva MD Device?

Venus Viva MD Device is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by Venus Concept USA, Inc.. The 510(k) number is K201164.

When was Venus Viva MD Device approved by the FDA?

Venus Viva MD Device received FDA 510(k) clearance on 2020-06-26, under approval number K201164.

What company makes Venus Viva MD Device?

Venus Viva MD Device is manufactured by Venus Concept USA, Inc..

What is the FDA product code for Venus Viva MD Device?

The FDA product code for Venus Viva MD Device is GEI.

Other Devices by Venus Concept USA, Inc.

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Related Devices (Code: GEI)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.