Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System

Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner below the surface of the skin.

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System to obtain improvement in overall lifting and tightening of skin.

Inclusion Criteria:

• Male or female, aged 30 to 65 years.
• Subject in good health.
• Skin laxity in the lower face and neck.
• Willingness and ability to comply with protocol requirements and return for follow-up visits.
• Provides written informed consent and HIPAA authorization.

Exclusion Criteria:

• Pregnant or lactating.
• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat in the face and lower neck.
• Excessive skin laxity on the face and neck.
• 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.