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FDA 510(k)

Venus BlissMAX

K-Number: K220592 · 2022-04-27

Decision Date2022-04-27
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venus BlissMAX is a medical device manufactured by Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2022-04-27 under approval number K220592. 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 2022-04-27. It is manufactured by Venus Concept USA, Inc.. The 510(k) number is K220592.

When was Venus BlissMAX approved by the FDA?

Venus BlissMAX received FDA 510(k) clearance on 2022-04-27, under approval number K220592.

What company makes Venus BlissMAX?

Venus BlissMAX is manufactured by Venus Concept USA, Inc..

What is the FDA product code for Venus BlissMAX?

The FDA product code for Venus BlissMAX is PBX.

Other Devices by Venus Concept USA, Inc.

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Related Devices (Code: PBX)

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.