Cleared Traditional

K163415 - SlimShape System

K163415 is an FDA 510(k) clearance for SlimShape System, manufactured by Syneron Medical, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K163415 · Syneron Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
136d
Days
Class 2
Risk

K163415 is an FDA 510(k) clearance for the SlimShape System. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Syneron Medical, Ltd. (Yokneam Illit, IL). The FDA issued a Cleared decision on April 20, 2017 after a review of 136 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 Syneron Medical, Ltd. devices

FDA 510(k) Submission Details - K163415

510(k) Number K163415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2016
Decision Date April 20, 2017
Days to Decision 136 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
21d slower than avg
Panel avg: 115d · This submission: 136d
Pathway characteristics
Predicate-based equivalence.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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
NCT02553278 Unknown Interventional Industry-sponsored

VelaShape and Contour I V3 for Abdominal Fat Reduction vs. Control

Clinical Study to Evaluate the Performances of Modified VelaShape and the Performance of Contour I V3 Devices for Abdominal Fat Reduction vs. Control

24
Patients (est.)
1
Site
Treatment
Purpose
Single blind
Masking
Condition studied Unwanted Abdomen Fat
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Dr. Dean Ad-El, M.D
Sponsor Syneron Medical (industry)
Started 2016-01-10 → Primary completion 2017-10-01 → Completed 2017-12-01
Primary outcome
histology following VelaShape treatment
View full study on ClinicalTrials.gov

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1749
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K163415.
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