V30 system, V20 system, V10 system, V-FC Handpiece— 510(k) K200468

Name: FDA 510(k) clearance K200468
Creator: U.S. Food and Drug Administration
Published: 2020-05-21

Substantially Equivalent

Viora , Ltd.

FDA 510(k) clearance K200468 for V30 system, V20 system, V10 system, V-FC Handpiece, Substantially Equivalent on 2020-05-21. 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: 2020-02-26
Decision date: 2020-05-21
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.