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FDA 510(k)

Venus Bliss

K-Number: K190743 · 2019-06-25

ApplicantVenus Concept USA, Inc.
Decision Date2019-06-25
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venus Bliss 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 2019-06-25 under 510(k) number K190743. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Venus Bliss?

Venus Bliss is a medical device that received FDA 510(k) clearance on 2019-06-25. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K190743.

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

Venus Bliss received FDA 510(k) clearance on 2019-06-25, under 510(k) number K190743.

Who is the listed applicant for Venus Bliss?

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 Bliss?

The FDA product code for Venus Bliss is PBX.

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.

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Related Devices (Code: PBX)

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.

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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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