Cleared Traditional

K201064 - V30 System

K201064 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 85-day FDA review.

K201064 · Viora , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
85d
Days
Class 2
Risk

K201064 is an FDA 510(k) clearance for the V30 System, V20 System, V10 System, V-FR Handpiece. 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 July 15, 2020 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Viora , Ltd. devices

Submission Details

510(k) Number K201064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2020
Decision Date July 15, 2020
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 K201064.
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
V30 system, V20 system, V10 system, V-FC Handpiece
K200468 · Viora , Ltd. · May 2020
TempSure System
K200241 · Cynosure, LLC · Mar 2020
CAPENERGY - C100, C200, C300, C400, C50
K191202 · Capenergy Medical S.L. · Feb 2020