Non-Invasive Reduction of Subcutaneous Fat Layer With an Alternative Treatment Parameter

The Number of Device and/or Procedure-Related Adverse Events

Time Frame: Enrollment through 16 weeks post-treatment visit, which is approximately 5 months

The number of device- or procedure-related adverse events will be tabulated. Adverse event reports are collected throughout the study from enrollment through the 16 week follow-up visit. The investigator determines if there is a relationship between the event and the study device or procedure.

Change in the Fat Layer of the Treated Area as Measured by Ultrasound

Time Frame: Pre-treatment and 16 weeks post-treatment

Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the untreated contralateral flank control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated flank as compared to the untreated control flank. Results indicate the fat layer reduction in millimeters.