Cleared Traditional

K160259 - ZELTIQ CoolSculpting System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160259 · Zeltiq Aesthetics, Inc. · General & Plastic Surgery device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 114d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.