Evaluation of the Ulthera System for the Treatment of the Decolletage

Exclusion Criteria

• •Presence of an active systemic or local skin disease that may affect wound healing.
• •Scarring in areas to be treated.
• •Tattoos in the areas to be treated.
• •Patients with ports or defibrillators.
• •Any open wounds or lesions in the area.
• •Active and severe inflammatory acne in the region to be treated.
• •Patients who have a history with keloid formation or hypertrophic scarring.
• •Inability to understand the protocol or to give informed consent.
• •Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the décolletage area within two weeks prior to study participation or during the study.
• •Marked décolletage asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
• •History of chronic drug or alcohol abuse.
• •History of autoimmune disease.
• •Concurrent therapy that would interfere with the evaluation of the safety or effectiveness of the study device.
• •Subjects who anticipate the need for surgery or overnight hospitalization during the study.
• •Subjects who have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
• •Concurrent enrollment in any study involving the use of investigational devices or drugs.
• •Current smoker or history of smoking in the last one year.
• •History of using the following prescription medications:
• •1. Topical Retinoids to the area within the past two weeks;
• •2. Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix).
• •3. Psychiatric drugs that would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.