This is a marketing study intended to provide additional data for marketing purposes for the eon™ FR is FDA 510(k) which has been cleared for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. This device is intended for individuals with a Body Mass Index (BMI) of 30 kg/m2 or less.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.
Fiala Aesthetics
Altamonte Springs, Florida, United States
Photographic Evaluations as a Measure of Effectiveness
Photographs of the treatment area will be obtained at baseline and 12 weeks post treatment and be evaluated by blinded independent readers to correctly identify pre-treatment (baseline) photographs compared to 12 weeks post treatment photographs in order to determine effectiveness of device.
Time frame: 12 Weeks
Change in Adipose Layer Thickness
Ultrasound measurements of adipose layer thickness will be collected at baseline and 12 weeks after procedure to evaluate changes between both.
Time frame: 12 weeks
Subject Satisfaction
Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure.
Time frame: 12 weeks
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