Cleared Traditional

K202247 - V30 system

K202247 is the FDA 510(k) clearance for V30 system by Viora , Ltd.. It is a Class 2 General & Plastic Surgery device (product code PBX) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K202247 · Viora , Ltd. · General & Plastic Surgery device
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Dec 2020
Decision
121d
Days
Class 2
Risk

K202247 is an FDA 510(k) clearance for the V30 system, V20 system, V10 system, V-VR Hand piece. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Viora , Ltd. (Neanya, IL). The FDA issued a Cleared decision on December 9, 2020 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Viora , Ltd. devices

Submission Details

510(k) Number K202247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2020
Decision Date December 09, 2020
Days to Decision 121 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PBX Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - PBX Massager, Vacuum, Radio Frequency Induced Heat

All 60
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K202247.
RF Thermal System
K210129 · Luvo Medical Technologies, Inc. · Jul 2021
Evolve System with the T3 Applicator
K210877 · Inmode , Ltd. · Jul 2021
NuEra Tight RF, NuEra Tight RF Plus
K210867 · Bios S.R.L. · Apr 2021
Palm NRG cellulite and muscle toning body device
K191940 · Heat IN A Click · Nov 2020
Ultimate Contour, Ultimate Contour Mini
K201475 · CAO Group, Inc. · Oct 2020
NuEra Tight, NuEra Tight EMS
K200359 · Bios S.R.L. · Aug 2020