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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 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 2020-06-26 under 510(k) 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. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K201164.

When did Venus Viva MD Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Venus Viva MD Device?

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 Viva MD Device?

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

Other records listing Venus Concept USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 10 devices →

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.