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FDA 510(k)

Venus BlissMAX

K-Number: K213308 · 2022-01-12

ApplicantVenus Concept USA, Inc.
Decision Date2022-01-12
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venus BlissMAX 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 2022-01-12 under 510(k) number K213308. 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 BlissMAX?

Venus BlissMAX is a medical device that received FDA 510(k) clearance on 2022-01-12. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K213308.

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

Venus BlissMAX received FDA 510(k) clearance on 2022-01-12, under 510(k) number K213308.

Who is the listed applicant for Venus BlissMAX?

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 BlissMAX?

The FDA product code for Venus BlissMAX 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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