Eon™ FR Clinical Study Protocol 1064

Exclusion Criteria

• •Aesthetic fat reduction procedure in the treatment area within the previous year.
• •Age less than 21 or greater than 60 years old.
• •Female subject pregnant or planning to become pregnant during the study duration,
• •Had an infection, dermatitis or a rash in the treatment area.
• •Had tattoos or jewelry in the treatment area.
• •Had a history of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• •Had a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• •Had a history of a known bleeding disorder.
• •Had a known photosensitivity to the study laser wavelength, history of ingesting. medications known to induce photosensitivity, or history of seizure disorders due to light.
• •Had known collagen, vascular disease or scleroderma.
• •Underwent a surgery or procedure in the treatment area within 6 months of treatment, which is still healing.
• •Had underwent a fat reduction procedure in the treatment area within the past 12 months.
• •Had a significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy.
• •Underwent systemic chemotherapy for the treatment of cancer.
• •Used gold therapy for disorders such as rheumatologic disease or lupus.
• •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 had any physical or mental condition which might make it unsafe for the subject to participate in this study.
• •Concurrent use of steroids or secondary rheumatoid drugs.
• •Prior liposuction or a tummy tuck in the study area.