Cleared Traditional

K162512 - truSculpt

K162512 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 Traditional 510(k) pathway after a 92-day FDA review.

K162512 · Cutera, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K162512

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

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. 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
NCT02489994 Unknown Interventional Industry-sponsored

Performance of the ePrime System for Cellulite

Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite

51
Patients (actual)
4
Sites
Treatment
Purpose
Open label
Masking
Condition studied Cellulite
Study design Single group
Eligibility Female only · 25 Years+ · Healthy volunteers accepted
Principal investigator Macrene Alexiades, MD
Sponsor Syneron Medical (industry)
Started 2014-10-01 → Primary completion 2016-08-01 → Completed 2016-10-01
Primary outcome
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs
Secondary outcome
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs
View full study on ClinicalTrials.gov

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

All 78
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K162512.
truSculpt
K172004 · Cutera, Inc. · Aug 2017
sensiFirm
K170637 · El Global Trade, Ltd. · Jul 2017
Exilis XP II
K163176 · BTL Industries, Inc. · Jan 2017
Indiba Diathermia Radiofrequency Device - Activ
K161458 · Indiba USA, Inc. · Oct 2016
TR-100
K161551 · BTL Industries, Inc. · Sep 2016
Profound System
K161043 · Syneron Candela Corporation · Sep 2016