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 a medical device manufactured by Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2021-10-14 under approval 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. It is manufactured by Venus Concept USA, Inc.. The 510(k) number is K211461.
When was Family of Venus RF Systems - Venus Freedom approved by the FDA?
Family of Venus RF Systems - Venus Freedom received FDA 510(k) clearance on 2021-10-14, under approval number K211461.
What company makes Family of Venus RF Systems - Venus Freedom?
Family of Venus RF Systems - Venus Freedom is manufactured by Venus Concept USA, Inc..
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.
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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.