Cleared Traditional

K180709 - truSculpt RF Device

Also marketed or referenced as:
truSculpt truSculpt 3D

K180709 is an FDA 510(k) clearance for truSculpt RF Device, 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 79-day FDA review.

K180709 · Cutera, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
79d
Days
Class 2
Risk

K180709 is an FDA 510(k) clearance for the truSculpt RF Device. 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 June 6, 2018 after a review of 79 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. 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 Cutera, Inc. devices

FDA 510(k) Submission Details - K180709

510(k) Number K180709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2018
Decision Date June 06, 2018
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
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
NCT03428243 Completed Observational Industry-sponsored

Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction

Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction: 18-month Circumference Measuing of Some C-16-TS11 Subjects.

14
Patients (actual)
1
Site
Condition studied Abdominal Fat
Eligibility All sexes · 24 Years+ · Healthy volunteers accepted
Principal investigator Stephen Ronan, MD
Sponsor Cutera Inc. (industry)
Started 2017-07-12 → Primary completion 2017-11-06 → Completed 2017-12-01
Primary outcome
Circumference Measurement
Secondary outcome
Device Safety
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
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 K180709.
T-PLUS
K181893 · Wintecare SA · Jan 2019
Human Tecar HCR 1002
K181211 · Unibell S.R.L · Sep 2018
RF-Relief
K181095 · El Global Trade, Ltd. · Jul 2018
InMode PLUS System
K172302 · Inmode MD , Ltd. · Dec 2017
Ultimate Contour, Ultimate Contour Mini
K171052 · CAO Group, Inc. · Oct 2017
Winback Back 3SE
K162828 · Winback USA Corp · Sep 2017