Eon™ FR 1064 Full Abdomen Clinical Study Protocol

Exclusion Criteria

• •Aesthetic fat reduction procedure in the treatment area within the previous year.
• •Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in last 6 months
• •Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months)
• •Subject has an infection, dermatitis or a rash in the treatment area.
• •Subject has tattoos or jewelry in the treatment area or within the treatment area site or photography frame.
• •Subject has a history of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• •Subject has a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• •Subject has a history of a known bleeding disorder.
• •Subject has a known photosensitivity to the study laser wavelength, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.
• •Subject has known collagen, vascular disease or scleroderma.
• •Subject has undergone a surgery or procedure in the treatment area within 6 months of treatment, which is still healing.
• •Subject suffers from significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy.
• •Subject is undergoing systemic chemotherapy for the treatment of cancer.
• •Subject is using gold therapy for disorders such as rheumatologic disease or lupus.
• •Subject has participated in a study of another device or drug within three months prior to enrollment or during the study.
• •As per the investigator's discretion, the subject has any physical or mental condition which might make it unsafe for the subject to participate in this study.
• •Subject has ongoing use of steroids or secondary rheumatoid drugs.
• •Subject is actively taking psychotropic medications.