Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum

Exclusion Criteria

• •Scarring in area(s) to be treated;
• •Any active implants (e.g., pacemakers or defibrillators) in the area(s) to be treated;
• •Any metallic implants in area(s) to be treated;
• •Any open wounds or lesions in the area(s) to be treated;
• •Body mass index (BMI) less than 19 or greater than 30; or
• •Gain or loss of ≥ 2 BMI units within the previous 90 days or has the intention to gain or lose ≥ 2 BMI units during the course of the trial.