Patients signed an affidavit stating that no personal lifestyle changes would be made throughout the study. Patients were required to track daily physical activity, daily calorie intake, and participation in any program or consumption of dietary supplement that could promote contouring.
FDA DETERMINED that a cumulative reduction of at least 3.0 inches were clinically meaningful. Patients received treatment every-other-day for two weeks for a total of just six treatments. Each treatment consisted of concurrent stimulation of waist, hips, and thighs for 20 minutes anterior and 20 minutes posterior (total treatment time of 40 minutes). Evaluation points were at baseline, weeks 1 and 2, along with a 2 week post-procedure follow-up.
“After review of the information submitted in the petition FDA has determined that laser therapy for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs can be classified in class II with the establishment of special controls. FDA believes that class II special controls provide reasonable assurance of the safety and effectiveness of the device type.”