Feasibility Study: Histological Characterization After Treatment With the Ulthera® System

This study is a prospective, single-center clinical trial. Subjects will be enrolled at the
investigator's discretion if they meet inclusion/ exclusion criteria and provide written
informed consent. Enrolled subjects will be treated with an assigned transducer based on
their order of enrollment. At the study follow-up visit, subjects will undergo resection of
the treated tissue for histological analysis prior to their planned rhytidectomy procedure.

Inclusion Criteria:

- Male or female, age 30 to 65 years scheduled for rhytidectomy.

- Subject in good health.

- Understands and accepts the obligation not to undergo any other procedures in the
areas to be treated.

- 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.

- Subjects of childbearing potential must have a negative urine pregnancy test result
and must not be lactating at Visit 1 and be willing and able to use an acceptable
method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal
methods, IUD, surgical sterilization, abstinence) during the study. Women will not be
considered of childbearing potential if one of the following conditions is documented
on the medical history: a) Postmenopausal for at least 12 months prior to study; b)
Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six
months prior to study enrollment.

Exclusion Criteria:

- Presence of an active systemic or local skin disease that may affect wound healing.

- Severe solar elastosis.

- 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.

- Presence of a metal stent or implant in the facial area to be treated.

- Inability to understand the protocol or to give informed consent.