Cleared Traditional

K181740 - ZELTIQ CoolSculpting System

K181740 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 58-day FDA review.

K181740 · Zeltiq Aesthetics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
58d
Days
Class 2
Risk

K181740 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 August 29, 2018 after a review of 58 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 - K181740

510(k) Number K181740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2018
Decision Date August 29, 2018
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.