Cleared Traditional

Family of Venus RF Systems - Venus Freedom (K211461) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 56
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