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
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
| 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