Non-Invasive Fat Reduction With Cryolipolysis for Jawline Contouring

Number of Participants With Unanticipated Adverse Device Effects (UADE)

Time Frame: Enrollment through study completion, an average of 6 months.

This outcome measurement considered all unanticipated device- or procedure-related adverse effects.

Number of Before and After Side-by-side Photograph Pairs Correctly Identified by At Least 2 of 3 Blinded, Independent Reviewers

Time Frame: Baseline through 12 weeks post second treatment.

Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment (baseline) and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which photographs will be presented will be randomized; for each subject placement of the baseline and pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success is defined as 75% correct identification of pre-treatment photos by 2 out of 3 reviewers.