Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté

Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté

Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.

This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.

Inclusion Criteria:

• Female, aged 35 to 60 years.
• Subject in good health.
• Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
• 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.
• Scarring in areas to be treated.
• Tattoos in the areas to be treated.
• Patients with ports or defibrillators.
• Breast size >400cc each as measured by water displacement method.
• History of breast reduction surgery.
• Any open wounds or lesions in the area.
• Active and severe inflammatory acne in the region to be treated.
• Patients who have a history with keloid formation or hypertropic scarring