Not Cleared Post-NSE

DEN090002 - ZELTIQ AESTHETICS DERMAL COOLING DEVICE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN090002 · Zeltiq Aesthetics · General & Plastic Surgery device
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Aug 2010
Decision
315d
Days
Class 2
Risk

DEN090002 is an FDA 510(k) submission (not cleared) for the ZELTIQ AESTHETICS DERMAL COOLING DEVICE. Classified as Dermal Cooling Pack/vacuum/massager (product code OOK), Class II - Special Controls.

Submitted by Zeltiq Aesthetics (Pleasanton, US). The FDA issued a Not Cleared (DENG) decision on August 24, 2010 after a review of 315 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 315 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Zeltiq Aesthetics devices

Submission Details

510(k) Number DEN090002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 13, 2009
Decision Date August 24, 2010
Days to Decision 315 days
Submission Type Post-NSE
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 114d · This submission: 315d
Pathway characteristics

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.