Cleared Traditional

K211461 - Family of Venus RF Systems - Venus Freedom

K211461 is an FDA 510(k) clearance for Family of Venus RF Systems - Venus Freedom, manufactured by Venus Concept USA, Inc.. The device is a Class 2 General & Plastic Surgery device with product code PBX cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K211461 · Venus Concept USA, Inc. · General & Plastic Surgery device
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Oct 2021
Decision
156d
Days
Class 2
Risk

K211461 is an FDA 510(k) clearance for the Family of Venus RF Systems - Venus Freedom. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Venus Concept USA, Inc. (Weston, US). The FDA issued a Cleared decision on October 14, 2021 after a review of 156 days - an extended review 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: 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 Venus Concept USA, Inc. devices

FDA 510(k) Submission Details - K211461

510(k) Number K211461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2021
Decision Date October 14, 2021
Days to Decision 156 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
41d slower than avg
Panel avg: 115d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PBX Device Classification - Class 2, Special Controls

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 65
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K211461.
Venus BlissMAX
K220592 · Venus Concept USA, Inc. · Apr 2022
Venus BlissMAX
K213308 · Venus Concept USA, Inc. · Jan 2022
Deka Tiac II
K211091 · El.En Electronic Engineering Spa · Oct 2021
Sectum
K202780 · Neauvia North America · Jul 2021
RF Thermal System
K210129 · Luvo Medical Technologies, Inc. · Jul 2021
Evolve System with the T3 Applicator
K210877 · Inmode , Ltd. · Jul 2021