Cleared Traditional

K162512 - truSculpt

K162512 is the FDA 510(k) clearance for truSculpt by Cutera, Inc.. It is a Class 2 General & Plastic Surgery device (product code PBX) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K162512 · Cutera, Inc. · General & Plastic Surgery device
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Dec 2016
Decision
92d
Days
Class 2
Risk

K162512 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 December 9, 2016 after a review of 92 days - within the typical 510(k) review window.

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. 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 Cutera, Inc. devices

Submission Details

510(k) Number K162512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2016
Decision Date December 09, 2016
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - PBX Massager, Vacuum, Radio Frequency Induced Heat

All 61
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K162512.
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truSculpt RF Device
K180709 · Cutera, Inc. · Jun 2018
Exilis XP II
K163176 · BTL Industries, Inc. · Jan 2017
TR-100
K161551 · BTL Industries, Inc. · Sep 2016
XP3000
K150720 · BTL Industries, Inc. · Sep 2015
Exilis XP
K143040 · BTL Industries, Inc. · Jan 2015