Cleared Traditional

K171052 - Ultimate Contour, Ultimate Contour Mini

K171052 is an FDA 510(k) clearance for Ultimate Contour, manufactured by CAO Group, Inc.. The device is a Class 2 General & Plastic Surgery device with product code PBX cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K171052 · CAO Group, Inc. · General & Plastic Surgery device
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Oct 2017
Decision
193d
Days
Class 2
Risk

K171052 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 20, 2017 after a review of 193 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 CAO Group, Inc. devices

FDA 510(k) Submission Details - K171052

510(k) Number K171052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2017
Decision Date October 20, 2017
Days to Decision 193 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
78d slower than avg
Panel avg: 115d · This submission: 193d
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 78
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K171052.
RF-Relief
K181095 · El Global Trade, Ltd. · Jul 2018
truSculpt RF Device
K180709 · Cutera, Inc. · Jun 2018
InMode PLUS System
K172302 · Inmode MD , Ltd. · Dec 2017
Winback Back 3SE
K162828 · Winback USA Corp · Sep 2017
truSculpt
K172004 · Cutera, Inc. · Aug 2017
sensiFirm
K170637 · El Global Trade, Ltd. · Jul 2017