CoolSculpting of the Distal Thigh Study

Exclusion Criteria

• •Subject has had a surgical procedure(s) in the area of intended treatment.
• •Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
• •Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
• •Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
• •Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
• •Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
• •Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• •Subject is taking or has taken diet pills or supplements within the past month.
• •Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
• •Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
• •Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
• •Subject is lactating or has been lactating in the past 6 months.
• •Subject is unable or unwilling to comply with the study requirements.
• •Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
• •Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.