K162163 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 17, 2016 after a review of 107 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
NCT02488083
Unknown
Interventional
Industry-sponsored
UltraShape Device for Thigh Fat and Circumference Reduction vs. Control
Clinical Study to Evaluate the Performance of the UltraShape Device for Thighs Fat and Circumference Reduction vs. Control
| Condition studied |
Unwanted Thigh Fat |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Robert Weiss, MD |
| Sponsor |
Syneron Medical
(industry)
|
Started 2015-06-01
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Primary completion 2016-12-01
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Completed 2017-03-01
Primary outcome
evaluate the efficacy of the UltraShape device by evaluating the non-invasive fat and circumference reduction
Secondary outcome
safety issues assessed by The number, severity and type of any adverse event recorded throughout the study and post treatment (immediate and delayed response)
View full study on ClinicalTrials.gov