Family of Venus RF Systems - Heal— 510(k) K182094

Name: FDA 510(k) clearance K182094
Creator: U.S. Food and Drug Administration
Published: 2019-02-01

Substantially Equivalent

Venus Concept USA, Inc.

FDA 510(k) clearance K182094 for Family of Venus RF Systems - Heal, Substantially Equivalent on 2019-02-01. Applicant: Venus Concept USA, Inc.. Device class: 2.

Clearance details

Applicant: Venus Concept USA, Inc.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2018-08-03
Decision date: 2019-02-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Weston, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.