Cleared Traditional

K151179 - ZELTIQ CoolSculpting System

K151179 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 141-day FDA review.

K151179 · Zeltiq Aesthetics, Inc. · General & Plastic Surgery device
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Sep 2015
Decision
141d
Days
Class 2
Risk

K151179 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 September 22, 2015 after a review of 141 days - within the typical 510(k) review window.

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 - K151179

510(k) Number K151179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2015
Decision Date September 22, 2015
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
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
NCT01859091 Completed Interventional Industry-sponsored

Pilot Study on the Submental Area

Pilot Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area Using Cryolipolysis

14
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Body Fat Disorder
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Zeltiq Aesthetics (industry)
Started 2013-10-01 → Primary completion 2014-10-01
Primary outcome
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
Secondary outcome
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
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 K151179.
ZELTIQ CoolSculpting System
K171069 · Zeltiq Aesthetics, Inc. · Jul 2017
ZELTIQ CoolSculpting System
K162050 · Zeltiq Aesthetics, Inc. · Nov 2016
ZELTIQ CoolSculpting System
K160259 · Zeltiq Aesthetics, Inc. · Mar 2016
ZEL TIQ CoolSculpting System
K142491 · Zeltiq Aesthetics, Inc. · Jan 2015
ZELTIQ COOLSCULPTING SYSTEM
K133212 · Zeltiq Aesthetics, Inc. · Apr 2014
ZELTIQ COOLSCULPTING
K120023 · Zeltiq Aesthetics, Inc. · May 2012