Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept, Inc.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) 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. The listed applicant is Venus Concept, Inc.. The 510(k) number is K252845.

When did Venus Nova (FP-2001) receive FDA 510(k) clearance?

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

Who is the listed applicant for Venus Nova (FP-2001)?

The FDA 510(k) record lists Venus Concept, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Venus Concept, 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.

K232192Venus Versa PRO SystemK162765Venus Velocity Diode Laser SystemK153717Venus Versa SystemK152790Venus Versa System

Related Devices (Code: GEI)

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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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.

↑