Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment Method

An Evaluation of the Safety and Effectiveness of Treatment of Adipose Tissue With the Liposonix System (Model 2) Using a New Treatment Method

The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment with the Liposonix System (Model 2)using a single pass technique.

Inclusion Criteria:

• Male or female, 18 to 65 years of age
• Body Mass Index of ≤30 kg/m2
• Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm
• Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study
• Subject must understand the nature of the study and sign an IRB approved Informed Consent

Exclusion Criteria:

• Subject is pregnant
• Subject is diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation
• Subject has diabetes or cardiovascular disease
• Subject has had prior aesthetic procedures to the region to be treated
• Subject has had previous open or laparoscopic surgery in the anticipated treatment area
• Subject is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures
• Subjects undergoing chronic steroid or immunosuppressive therapy
• Subject has cardiac pacemakers or any implantable electrical device
• Subject has a History of cancer
• Subject has sensory loss or dysesthesia in the area to be treated
• Subjects who are unable, or lack the capacity, to self consent