Cleared Traditional

K213308 - Venus BlissMAX

K213308 is an FDA 510(k) clearance for Venus BlissMAX, manufactured by Venus Concept USA, Inc.. The device is a Class 2 Physical Medicine device with product code PBX cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K213308 · Venus Concept USA, Inc. · Physical Medicine device
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Jan 2022
Decision
100d
Days
Class 2
Risk

K213308 is an FDA 510(k) clearance for the Venus BlissMAX. 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 January 12, 2022 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 878.4400 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Venus Concept USA, Inc. devices

FDA 510(k) Submission Details - K213308

510(k) Number K213308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2021
Decision Date January 12, 2022
Days to Decision 100 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
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 Physical Medicine 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 K213308.
Apollo Duet (Model : APD-4000)
K212253 · Weero Co. · Aug 2022
Diacare 7000
K211207 · Globus Sport and Health Technologies, LLC · Jun 2022
Venus BlissMAX
K220592 · Venus Concept USA, Inc. · Apr 2022
Deka Tiac II
K211091 · El.En Electronic Engineering Spa · Oct 2021
Family of Venus RF Systems - Venus Freedom
K211461 · Venus Concept USA, Inc. · Oct 2021
Sectum
K202780 · Neauvia North America · Jul 2021