Cleared Traditional

K150505 - Cellfina System

K150505 is an FDA 510(k) clearance for Cellfina System, manufactured by Ulthera, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OUP cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K150505 · Ulthera, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
154d
Days
Class 2
Risk

K150505 is an FDA 510(k) clearance for the Cellfina System. Classified as Powered Surgical Instrument For Improvement In The Appearance Of Cellulite (product code OUP), Class II - Special Controls.

Submitted by Ulthera, Inc. (Mesa, US). The FDA issued a Cleared decision on July 29, 2015 after a review of 154 days - an extended review cycle.

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.

View all Ulthera, Inc. devices

FDA 510(k) Submission Details - K150505

510(k) Number K150505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2015
Decision Date July 29, 2015
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
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

Regulatory Peers - OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

All 8
Devices cleared under the same product code (OUP) and FDA review panel - the closest regulatory comparables to K150505.
The Cellfina System
K192185 · Ulthera, Inc. · Oct 2019
The Cellfina System
K161885 · Ulthera, Inc. · Oct 2016
The Cellfina System
K153677 · Ulthera, Inc. · Feb 2016
CABOCHON SYSTEM
K134010 · Cabochon Aesthetics, Inc. · Apr 2014
CABOCHON SYSTEM
DEN110004 · Cabochon Aesthetics, Inc. · Jul 2013