Ultherapy for the Treatment of Spider Veins on the Legs

Inclusion Criteria

• •Female, age 18 years or older.
• •Subject in good health.
• •Fitzpatrick Skin Types I-III.
• •Understands and accepts the obligation not to undergo any other elective procedures, i.e., laser and IPL, in the areas to be treated through the follow-up period.
• •Has up to 4 separate spider veins measuring up to 2 cm in length at a depth of approximately 1.0mm.
• •Has lower extremity spider veins ≤1.0mm in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the Investigator.
• •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 the Screening Visit 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:
• •1. Postmenopausal for at least 12 months prior to study;
• •2. Without a uterus and/or both ovaries; or
• •3. Bilateral tubal ligation at least six months prior to study enrollment.
• •Absence of physical or psychological conditions unacceptable to the investigator.
• •Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID prior to each study treatment and chronic use during the entire post-treatment study period. Washout period, if chronic user, for 4 weeks prior to the first treatment. Washout period for limited acute NSAID use, i.e., a maximum of 2-3 doses, is required in the 2 weeks prior to any study treatment visit.
• •Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
• •Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure