V30 System, V20 System, V10 System, V-FR Handpiece— 510(k) K201064

Name: FDA 510(k) clearance K201064
Creator: U.S. Food and Drug Administration
Published: 2020-07-15

Substantially Equivalent

Viora , Ltd.

FDA 510(k) clearance K201064 for V30 System, V20 System, V10 System, V-FR Handpiece, Substantially Equivalent on 2020-07-15. Applicant: Viora , Ltd.. Device class: 2.

Clearance details

Applicant: Viora , Ltd.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2020-04-21
Decision date: 2020-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neanya, IL

Download summary PDF View on FDA.gov ↗

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K152611 — V20 system2016-02-19
K150035 — V10 system2015-05-01

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