Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes

Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Periorbital Wrinkles

The purpose of this study is to look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes.

The purpose of this prospective, multi-center, single treatment, clinical trial is to evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment of periorbital wrinkles and rhytids.

Inclusion Criteria:

• Male or female, aged 40 to 70 years
• Subject in good health
• Desire improvement in periorbital wrinkles
• Subject provides informed consent and agrees to attend follow-up visits
• Subject signs a HIPPA authorization

Exclusion Criteria:

• Pregnant or lactating
• Has an active systemic or local skin disease that may alter wound healing
• Has significant scarring in test areas
• Has significant open facial wounds or lesions
• Has severe or cystic acne on the face
• Has a metal stent or implant in the face area
• Is a current smoker or has a history of smoking in last 10 years