Evaluation of the Ulthera® System for Treatment of the Face and Neck

Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity

Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

Inclusion Criteria:

• Male or female, aged 30 to 65 years.
• Subject in good health.
• Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
• Mild to moderate rhytids in the periorbital or perioral region.
• Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
• Mild to moderate vertical perioral lines
• Mild to moderate marionette lines.
• Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in 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 follow-up 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 cheek.
• Excessive skin laxity on the lower face and neck.
• Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
• Excessive hooding with or without redundant skin in the areas to be treated.