Cleared Traditional

K161952 - UltraShape System

K161952 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 115-day FDA review.

K161952 · Syneron Medical, Ltd. · General & Plastic Surgery device
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Nov 2016
Decision
115d
Days
Class 2
Risk

K161952 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. (Yokneam Illit, IL). The FDA issued a Cleared decision on November 7, 2016 after a review of 115 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 K161952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2016
Decision Date November 07, 2016
Days to Decision 115 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
At panel average
Panel avg: 115d · This submission: 115d
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.

Regulatory Consultant

Hogan Lovells US LLP
Janice M. Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02465775 Unknown Interventional Industry-sponsored

Fat Reduction in the Flanks Area vs. Control

Clinical Study to Evaluate the Performance of the UltraShape Device for Fat Reduction Treatment in the Flanks Area vs. Control

60
Patients (est.)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Flanks Fat Reduction vs. Control
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Robert Weiss, MD
Sponsor Syneron Medical (industry)
Started 2015-07-01 → Primary completion 2017-09-01 → Completed 2017-12-01
Primary outcome
efficacy of flank fat reduction vs. control
Secondary outcome
Fat thickness reduction on the treated flank
View full study on ClinicalTrials.gov

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

All 22
Devices cleared under the same product code (OHV) and FDA review panel - the closest regulatory comparables to K161952.
Ulthera System
K180623 · Ulthera, Inc. · May 2018
ULTRASHAPE POWER SYSTEM
K170370 · Syneron Medical, Ltd. · May 2017
UltraShape System
K162163 · 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