V30 system, V20 system, V10 system, V-VR Hand piece— 510(k) K202247

Name: FDA 510(k) clearance K202247
Creator: U.S. Food and Drug Administration
Published: 2020-12-09

Substantially Equivalent

Viora , Ltd.

FDA 510(k) clearance K202247 for V30 system, V20 system, V10 system, V-VR Hand piece, Substantially Equivalent on 2020-12-09. 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: 2020-08-10
Decision date: 2020-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neanya, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

view all

K253480 — Capenergy C Equipments RF C200 and C400 Drakarian2026-07-10
K260647 — SPECCHIO2026-04-02
K253261 — Apollo Quattro (APQ-10M)2026-03-13
K252888 — NeoSculpt Plus2026-03-09
K250734 — OptiLUV Device2025-09-10

More clearances from Viora , Ltd.

view all

K201064 — V30 System, V20 System, V10 System, V-FR Handpiece2020-07-15
K200468 — V30 system, V20 system, V10 system, V-FC Handpiece2020-05-21
K162363 — V30 system, V-Form Handpiece BC Medium applicator2016-11-18
K152611 — V20 system2016-02-19
K150035 — V10 system2015-05-01

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