Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue

Evaluation of the Ulthera™ System For Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity

The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin

The primary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment to obtain lift and tighten the cheek tissue.

The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.

Inclusion Criteria:

• Male or female, aged 35 to 60 years
• Subject in good health
• Desire lift and tightening of cheek tissue, improvement of jawline definition or submental skin laxity

Exclusion Criteria:

• Pregnant or lactating
• Has an active systemic or local skin disease that may alter wound healing
• Severe solar elastosis
• Excessive subcutaneous fat on the cheeks
• Excessive skin laxity on the lower face and neck
• Has significant scarring in areas to be treated
• Has significant open facial wounds or lesions
• Has severe or cystic acne on the face