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FDA 510(k)

Venus Nova (FP-2001)

K-Number: K252845 · 2025-11-06

ApplicantVenus Concept, Inc.
Decision Date2025-11-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venus Nova (FP-2001) is a medical device manufactured by Venus Concept, Inc.. It received FDA 510(k) clearance on 2025-11-06 under approval number K252845. 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 Nova (FP-2001)?

Venus Nova (FP-2001) is a medical device that received FDA 510(k) clearance on 2025-11-06. It is manufactured by Venus Concept, Inc.. The 510(k) number is K252845.

When was Venus Nova (FP-2001) approved by the FDA?

Venus Nova (FP-2001) received FDA 510(k) clearance on 2025-11-06, under approval number K252845.

What company makes Venus Nova (FP-2001)?

Venus Nova (FP-2001) is manufactured by Venus Concept, Inc..

What is the FDA product code for Venus Nova (FP-2001)?

The FDA product code for Venus Nova (FP-2001) is GEI.

Other Devices by Venus Concept, Inc.

K232192Venus Versa PRO System

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Official Source

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