Cleared Traditional

K133212 - ZELTIQ COOLSCULPTING SYSTEM

K133212 is an FDA 510(k) clearance for ZELTIQ COOLSCULPTING SYSTEM, manufactured by Zeltiq Aesthetics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OOK cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K133212 · Zeltiq Aesthetics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
173d
Days
Class 2
Risk

K133212 is an FDA 510(k) clearance for the ZELTIQ COOLSCULPTING SYSTEM. Classified as Dermal Cooling Pack/vacuum/massager (product code OOK), Class II - Special Controls.

Submitted by Zeltiq Aesthetics, Inc. (Pleasanton, US). The FDA issued a Cleared decision on April 9, 2014 after a review of 173 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. devices

FDA 510(k) Submission Details - K133212

510(k) Number K133212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2013
Decision Date April 09, 2014
Days to Decision 173 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
58d slower than avg
Panel avg: 115d · This submission: 173d
Pathway characteristics
Predicate-based equivalence.

OOK Device Classification - Class 2, Special Controls

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. 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
NCT01517659 Completed Interventional Industry-sponsored

Non-Invasive Reduction of Fat in the Inner Thighs

Non-Invasive Reduction of Fat in the Inner Thighs With the Zeltiq Coolsculpting System

45
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Body Fat Disorder
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Suzanne Kilmer, MD
Sponsor Zeltiq Aesthetics (industry)
Started 2012-12-01 → Primary completion 2014-02-12 → Completed 2014-10-01
Primary outcome
Percentage of Pre-Treatment Images Correctly Identified by Reviewers
Secondary outcome
Subject Satisfaction
View full study on ClinicalTrials.gov

Regulatory Peers - OOK Dermal Cooling Pack/vacuum/massager

All 13
Devices cleared under the same product code (OOK) and FDA review panel - the closest regulatory comparables to K133212.
ZELTIQ CoolSculpting System
K160259 · Zeltiq Aesthetics, Inc. · Mar 2016
ZELTIQ CoolSculpting System
K151179 · Zeltiq Aesthetics, Inc. · Sep 2015
ZEL TIQ CoolSculpting System
K142491 · Zeltiq Aesthetics, Inc. · Jan 2015
ZELTIQ COOLSCULPTING
K120023 · Zeltiq Aesthetics, Inc. · May 2012
ZELTIQ AESTHETICS DERMAL COOLING DEVICE
DEN090002 · Zeltiq Aesthetics · Aug 2010