Cleared Traditional

K162050 - ZELTIQ CoolSculpting System

K162050 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 119-day FDA review.

K162050 · Zeltiq Aesthetics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
119d
Days
Class 2
Risk

K162050 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 November 21, 2016 after a review of 119 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 - K162050

510(k) Number K162050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2016
Decision Date November 21, 2016
Days to Decision 119 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
4d slower than avg
Panel avg: 115d · This submission: 119d
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 K162050.
ZELTIQ CoolSculpting System
K181740 · Zeltiq Aesthetics, Inc. · Aug 2018
CoolSculpting System
K172144 · Zeltiq Aesthetics · Nov 2017
ZELTIQ CoolSculpting System
K171069 · Zeltiq Aesthetics, Inc. · Jul 2017
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