Cleared Traditional

K134032 - ULTHERA SYSTEM

K134032 is an FDA 510(k) clearance for ULTHERA SYSTEM, manufactured by Ulthera, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OHV cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K134032 · Ulthera, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
171d
Days
Class 2
Risk

K134032 is an FDA 510(k) clearance for the ULTHERA SYSTEM. Classified as Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (product code OHV), Class II - Special Controls.

Submitted by Ulthera, Inc. (Mesa, US). The FDA issued a Cleared decision on June 20, 2014 after a review of 171 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4590 - 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 Ulthera, Inc. devices

FDA 510(k) Submission Details - K134032

510(k) Number K134032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2013
Decision Date June 20, 2014
Days to Decision 171 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
56d slower than avg
Panel avg: 115d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

OHV Device Classification - Class 2, Special Controls

Product Code OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4590
Definition A Device Using Focused Ultrasound To Produce Localized, Mechanical Motion Within Tissues And Cells For The Purpose Of Producing Either Localized Heating For Tissue Coagulation Or For Mechanical Cellular Membrane Disruption Intended For Non-invasive Aesthetic Use.
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
NCT01713686 Completed Interventional Industry-sponsored

Evaluation of the Ulthera System for the Treatment of the Decolletage

Prospective, Multi-center, Pivotal Trial Evaluating the Safety and Effectiveness of the Ulthera® System for Improvement in Lines and Wrinkles of the Décolletage

129
Patients (actual)
4
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Chest Wrinkles
Study design Single group
Eligibility Female only · 35 Years+ · Healthy volunteers accepted
Principal investigator Mitchel P Goldman, MD
Sponsor Ulthera, Inc (industry)
Started 2012-10-01 → Primary completion 2013-08-01
Primary outcome
Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment
Secondary outcome
Overall Aesthetic Improvement at 90 Days Post-treatment
View full study on ClinicalTrials.gov

Regulatory Peers - OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

All 29
Devices cleared under the same product code (OHV) and FDA review panel - the closest regulatory comparables to K134032.
UltraShape System
K161952 · Syneron Medical, Ltd. · Nov 2016
ULTRASHAPE POWER SYSTEM
K160896 · Syneron Medical, Ltd. · Jul 2016
ULTRASHAPE SYSTEM
K141708 · Syneron Medical, Ltd. · Oct 2014
CONTOUR I V3.1 SYSTEM
K133238 · Syneron Medical, Ltd. · Apr 2014
ULTHERA SYSTEM
K132028 · Ulthera, Inc. · Dec 2013
ULTHERA SYSTEM
K121700 · Ulthera, Inc. · Oct 2012