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

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.