Treatment of the Face and Neck With Lower Ulthera System Energy Settings

Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck With Lower Energy Settings

Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

This trial is a prospective, single-site, double-blinded, randomized, split-face design. Subjects will be randomized to one of three treatment groups, receiving treatment using different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

Inclusion Criteria:

• Male or female, age 30 to 65 years.
• Subject in good health.
• Skin laxity on the face and neck

Exclusion Criteria:

• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat in the face or neck.
• Excessive skin laxity on the face or neck.
• Significant scarring in areas to be treated.
• Open wounds or lesions in the area to be treated.
• Severe or cystic acne on the area to be treated.