Cleared Traditional

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

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192185 · Ulthera, Inc. · General & Plastic Surgery device
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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
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 114d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.