Cleared Traditional

K160259 - ZELTIQ CoolSculpting System

K160259 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 51-day FDA review.

K160259 · Zeltiq Aesthetics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
51d
Days
Class 2
Risk

K160259 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 March 23, 2016 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zeltiq Aesthetics, Inc. devices

FDA 510(k) Submission Details - K160259

510(k) Number K160259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2016
Decision Date March 23, 2016
Days to Decision 51 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
64d faster than avg
Panel avg: 115d · This submission: 51d
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
NCT02669329 Completed Interventional Industry-sponsored

CoolSculpting the Upper Arm Study

CoolSculpting the Upper Arm Using a Vacuum Applicator

30
Patients (actual)
2
Sites
Other
Purpose
Open label
Masking
Condition studied Body Fat Disorder
Study design Single group
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Sponsor Zeltiq Aesthetics (industry)
Started 2016-02-05 → Primary completion 2016-06-07
Primary outcome
Percentage of Pre-treatment Images Correctly Identified
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 K160259.
CoolSculpting System
K172144 · Zeltiq Aesthetics · Nov 2017
ZELTIQ CoolSculpting System
K171069 · Zeltiq Aesthetics, Inc. · Jul 2017
ZELTIQ CoolSculpting System
K162050 · Zeltiq Aesthetics, Inc. · Nov 2016
ZELTIQ CoolSculpting System
K151179 · Zeltiq Aesthetics, Inc. · Sep 2015
ZEL TIQ CoolSculpting System
K142491 · Zeltiq Aesthetics, Inc. · Jan 2015
ZELTIQ COOLSCULPTING SYSTEM
K133212 · Zeltiq Aesthetics, Inc. · Apr 2014