Reducing Wrinkles Around the Eyes Using the Ulthera® System

Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes

The purpose of this prospective, multi-center, single treatment study is to evaluate the clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of the skin.

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.

Inclusion Criteria:

• Male or female, aged 30 to 65 years.
• Subject in good health.
• Mild to moderate rhytids in the periorbital region.
• Willingness and ability to comply with protocol requirements and return for follow-up visits.
• Not pregnant.
• Provide written informed consent and HIPAA authorization.

Exclusion Criteria:

• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat in the face.
• Deep wrinkles, numerous lines, with or without redundant skin in the area to be treated.
• Excessive hooding, with or without redundant skin, in the areas to be treated.
• Significant scarring in areas to be treated.
• Significant open facial wounds or lesions.
• Severe or cystic acne on the face.
• Presence of a metal stent or implant in the facial area to be treated.