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)

Family of Venus RF Systems - Venus Freedom

K-Number: K211461 · 2021-10-14

ApplicantVenus Concept USA, Inc.
Decision Date2021-10-14
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Family of Venus RF Systems - Venus Freedom 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 2021-10-14 under 510(k) number K211461. 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 Family of Venus RF Systems - Venus Freedom?

Family of Venus RF Systems - Venus Freedom is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K211461.

When did Family of Venus RF Systems - Venus Freedom receive FDA 510(k) clearance?

Family of Venus RF Systems - Venus Freedom received FDA 510(k) clearance on 2021-10-14, under 510(k) number K211461.

Who is the listed applicant for Family of Venus RF Systems - Venus Freedom?

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 Family of Venus RF Systems - Venus Freedom?

The FDA product code for Family of Venus RF Systems - Venus Freedom 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.

K221011AI.ME SystemK220592Venus BlissMAXK213308Venus BlissMAXK201164Venus Viva MD DeviceK200786Venus EpileveK191065Venus VivaTM

View all 10 devices →

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.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

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.

↑