Evaluation of Procedural Analgesia for Liposonix Treatment

Inclusion Criteria:

- Subject is an adult female or male, 18 to 65 years of age.

- Subject must weigh more than 120 pounds.

- Subject must have a Body Mass Index of ≤ 30 kg/m2.

- Subject must have thickness of skin + subcutaneous adipose tissue in the anticipated
treatment area of ≥ 2.3 cm.

- Subject must be able to read, write, speak, and understand English.

Exclusion Criteria:

- Female subject who is pregnant, is suspected to be pregnant, or is lactating

- Subjects 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 any aesthetic procedure to the region to be treated within past 6
months

- Subject has systemic skin disease or skin disease in the area to be treated

- Subject has any abnormality of the skin or soft tissues of the abdominal wall in the
area to be treated

- Subject has had previous open or laparoscopic surgery in the anticipated treatment
area

- Subjects is on prescription or over the counter weight reduction medication or
programs, or had weight reduction procedures

- Subject has skin or superficial tissue that does not lie flat on its own when the
subject is in the supine position

- Subjects undergoing chronic steroid or immunosuppressive therapy

- Subjects who have cardiac pacemakers or any implantable electrical device

- Subjects who have metal implants of any type in the area to be treated

- History of cancer

- Subjects who have sensory loss or dysesthesia in the area to be treated

- Subjects taking chronic benzodiazepines or opiates

- Subjects with a history of severe nausea/vomiting with opioid analgesics

- Subjects with sleep apnea

- Subjects with known allergies or sensitivities to study drugs

- Subjects with liver disease

- Subjects with renal failure