Cleared Traditional

Ultimate Contour, Ultimate Contour Mini (K201475) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K201475 · CAO Group, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
147d
Days
Class 2
Risk

K201475 is an FDA 510(k) clearance for the Ultimate Contour, Ultimate Contour Mini. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by CAO Group, Inc. (West Jordan, US). The FDA issued a Cleared decision on October 28, 2020 after a review of 147 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 CAO Group, Inc. devices

Submission Details

510(k) Number K201475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2020
Decision Date October 28, 2020
Days to Decision 147 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
32d slower than avg
Panel avg: 115d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04206384 Completed Interventional Industry-sponsored

Low-Frequency, High-Intensity Ultrasound for Waist Circumference Reduction

Efficacy of Low-Frequency, High-Intensity Ultrasound for Reduction in Subdermal Adipose Layers

52
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Abdominal Subcutaneous Fat
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor CAO Group, Inc. (industry)
Started 2019-12-02 → Primary completion 2020-05-01 → Completed 2020-05-12
Primary outcome
Waist Circumference Change
Secondary outcome
Number of Participants With Pain
View full study on ClinicalTrials.gov

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

All 77
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K201475.
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