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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2020-04-01 under 510(k) 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. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K191065.

When did Venus VivaTM receive FDA 510(k) clearance?

Venus VivaTM received FDA 510(k) clearance on 2020-04-01, under 510(k) number K191065.

Who is the listed applicant for Venus VivaTM?

The FDA 510(k) record lists Venus Concept USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venus VivaTM?

The FDA product code for Venus VivaTM is GEI.

Other records listing Venus Concept USA, Inc. as applicant

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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.

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