Cleared Traditional

K141708 - ULTRASHAPE SYSTEM

K141708 is the FDA 510(k) clearance for ULTRASHAPE SYSTEM by Syneron Medical, Ltd.. It is a Class 2 General & Plastic Surgery device (product code OHV) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K141708 · Syneron Medical, Ltd. · General & Plastic Surgery device
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Oct 2014
Decision
104d
Days
Class 2
Risk

K141708 is an FDA 510(k) clearance for the ULTRASHAPE SYSTEM. Classified as Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (product code OHV), Class II - Special Controls.

Submitted by Syneron Medical, Ltd. (Philedelphia, US). The FDA issued a Cleared decision on October 6, 2014 after a review of 104 days - within the typical 510(k) review window.

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 Syneron Medical, Ltd. devices

Submission Details

510(k) Number K141708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2014
Decision Date October 06, 2014
Days to Decision 104 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
11d faster than avg
Panel avg: 115d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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
NCT02154113 Completed Interventional Industry-sponsored

Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction

Baseline Controlled Two-arm Multi-Center Study to Evaluate the Safety and Efficacy of Combined Multi-Focus Treatments of UltraShape® Contour I V3 System and VelaShape II Device for Non-Invasive Circumference Reduction

21
Patients (actual)
2
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Abdominal Fat
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Shlomit Mann
Sponsor Syneron Medical (industry)
Started 2012-10-01 → Primary completion 2013-08-01 → Completed 2013-09-01
Primary outcome
Difference in circumference reduction between baseline and follow-up visits
Secondary outcome
Adverse Events
Study completed - no results published. This trial concluded in 2013 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