Cleared Special

K153677 - The Cellfina System (FDA 510(k) Clearance)

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

K153677 · Ulthera, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
66d
Days
Class 2
Risk

K153677 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 February 25, 2016 after a review of 66 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ulthera, Inc. devices

Submission Details

510(k) Number K153677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date February 25, 2016
Days to Decision 66 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 114d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

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.