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FDA 510(k)

Venus Legacy Pro Device

K-Number: K191528 · 2019-09-06

ApplicantVenus Concept USA, Inc.
Decision Date2019-09-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venus Legacy Pro 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 2019-09-06 under 510(k) 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. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K191528.

When did Venus Legacy Pro Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Venus Legacy Pro 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 Legacy Pro Device?

The FDA product code for Venus Legacy Pro Device 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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