Lifting and Tightening of the Face and Neck Following an Increased Density Treatment

Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment.

The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.

All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.

Inclusion Criteria:

• Male or female, aged 30 to 65 years
• Subject in good health
• Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
• Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study

Exclusion Criteria:

• Presence of an active systemic or local skin disease that may affect wound healing
• Severe solar elastosis
• Excessive subcutaneous fat on the cheeks
• Excessive skin laxity on the lower face and neck
• Significant scarring in areas to be treated
• Significant open facial wounds or lesions
• Severe or cystic acne on the face
• Presence of a metal stent or implant in the facial area to be treated, a pacemaker, or cochlear implants