Not Cleared Post-NSE

DEN110004 - CABOCHON SYSTEM (FDA 510(k) Clearance)

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

DEN110004 · Cabochon Aesthetics, Inc. · General & Plastic Surgery device
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Jul 2013
Decision
620d
Days
Class 2
Risk

DEN110004 is an FDA 510(k) submission (not cleared) for the CABOCHON SYSTEM. Classified as Powered Surgical Instrument For Improvement In The Appearance Of Cellulite (product code OUP), Class II - Special Controls.

Submitted by Cabochon Aesthetics, Inc. (Menlo Park, US). The FDA issued a Not Cleared (DENG) decision on July 12, 2013 after a review of 620 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4790 - 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 620 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 Cabochon Aesthetics, Inc. devices

Submission Details

510(k) Number DEN110004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 31, 2011
Decision Date July 12, 2013
Days to Decision 620 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
506d slower than avg
Panel avg: 114d · This submission: 620d
Pathway characteristics

Device Classification

Product Code OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4790
Definition Used For Controlled Release Of Subcutaneous Tissue For Improvement In The Appearance Of Cellulite.
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.