Cleared Traditional

K233732 - CoolSculpting Elite System (FDA 510(k) Clearance)

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

K233732 · Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics · General & Plastic Surgery device
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Sep 2024
Decision
296d
Days
Class 2
Risk

K233732 is an FDA 510(k) clearance for the CoolSculpting Elite System. Classified as Dermal Cooling Pack/vacuum/massager (product code OOK), Class II - Special Controls.

Submitted by Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics (Pleasanton, US). The FDA issued a Cleared decision on September 12, 2024 after a review of 296 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4340 - 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 Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics devices

Submission Details

510(k) Number K233732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2023
Decision Date September 12, 2024
Days to Decision 296 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
182d slower than avg
Panel avg: 114d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OOK Dermal Cooling Pack/vacuum/massager
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4340
Definition The Device Is A Combination Of A Cooling Pad Associated With A Vacuum Or Mechanical Massager Intended For The Disruption Or Induction Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumference Of Body Areas.
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.