FDA 510(k)

Venus Legacy Pro Device

K-Number: K191528 · 2019-09-06

Decision Date2019-09-06

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Venus Legacy Pro Device is a medical device manufactured by Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2019-09-06 under approval number K191528. 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 Legacy Pro Device?

Venus Legacy Pro Device is a medical device that received FDA 510(k) clearance on 2019-09-06. It is manufactured by Venus Concept USA, Inc.. The 510(k) number is K191528.

When was Venus Legacy Pro Device approved by the FDA?

Venus Legacy Pro Device received FDA 510(k) clearance on 2019-09-06, under approval number K191528.

What company makes Venus Legacy Pro Device?

Venus Legacy Pro Device is manufactured by Venus Concept USA, Inc..

What is the FDA product code for Venus Legacy Pro Device?

The FDA product code for Venus Legacy Pro Device is GEI.

Other Devices by Venus Concept USA, Inc.

K190743Venus Bliss K182094Family of Venus RF Systems - Heal K201164Venus Viva MD Device K200786Venus Epileve K191065Venus VivaTM K211461Family of Venus RF Systems - Venus Freedom

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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.