Cleared Traditional

The Cellfina System (K192185) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K192185 · Ulthera, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
58d
Days
Class 2
Risk

K192185 is an FDA 510(k) clearance for the 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 October 9, 2019 after a review of 58 days - a notably fast clearance 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: 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 Ulthera, Inc. devices

Submission Details

510(k) Number K192185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2019
Decision Date October 09, 2019
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

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. 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