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FDA 510(k)

Family of Venus RF Systems - Heal

K-Number: K182094 · 2019-02-01

ApplicantVenus Concept USA, Inc.
Decision Date2019-02-01
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Family of Venus RF Systems - Heal 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 2019-02-01 under 510(k) number K182094. 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 - Heal?

Family of Venus RF Systems - Heal is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K182094.

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

Family of Venus RF Systems - Heal received FDA 510(k) clearance on 2019-02-01, under 510(k) number K182094.

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

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 - Heal?

The FDA product code for Family of Venus RF Systems - Heal is PBX.

Other records listing Venus Concept USA, Inc. as applicant

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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.

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