Cleared Traditional

K134010 - CABOCHON SYSTEM

K134010 is an FDA 510(k) clearance for CABOCHON SYSTEM, manufactured by Cabochon Aesthetics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OUP cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K134010 · Cabochon Aesthetics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
105d
Days
Class 2
Risk

K134010 is an FDA 510(k) clearance 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 Cleared decision on April 14, 2014 after a review of 105 days - within the typical 510(k) review window.

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 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.

FDA 510(k) Submission Details - K134010

510(k) Number K134010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2013
Decision Date April 14, 2014
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

OUP Device Classification - Class 2, Special Controls

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. 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
NCT01671839 Completed Interventional Industry-sponsored

Study of the Cabochon System for Improvement in the Appearance of Cellulite

Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite

55
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Gynoid Lipodystrophy
Study design Single group
Eligibility Female only · 18 Years+ · Healthy volunteers accepted
Principal investigator Michael S Kaminer
Sponsor Merz North America, Inc. (industry)
Started 2012-08-01 → Primary completion 2013-09-01 → Completed 2015-12-01
Primary outcome
Mean Change (Decrease) in Cellulite Severity
Secondary outcome
Improvement in Cellulite Severity Grade
View full study on ClinicalTrials.gov
K134010 · CABOCHON SYSTEM
Download PDF FDA Summary Cabochon Aesthetics, …