Cleared Special

K122389 - TRUSCULPT

K122389 is an FDA 510(k) clearance for TRUSCULPT, manufactured by Cutera, Inc.. The device is a Class 2 General & Plastic Surgery device with product code PBX cleared through the Special 510(k) pathway after a 87-day FDA review.

K122389 · Cutera, Inc. · General & Plastic Surgery device
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Nov 2012
Decision
87d
Days
Class 2
Risk

K122389 is an FDA 510(k) clearance for the TRUSCULPT. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Cutera, Inc. (Brisbane, US). The FDA issued a Cleared decision on November 2, 2012 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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.

FDA 510(k) Submission Details - K122389

510(k) Number K122389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2012
Decision Date November 02, 2012
Days to Decision 87 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

PBX Device Classification - Class 2, Special Controls

Product Code PBX Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction 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.

K122389 · TRUSCULPT
Download PDF Cutera, Inc.