Eon™ FR Clinical Study Protocol 1064

This study evaluates the treatment of subjects between 18-60 with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue in the abdomen.

Inclusion criteria

• Body Mass Index (BMI) of 30 kg/m2 or less.
• Healthy male or female between the ages of 21 and 60.
• Had, at least 25 mm thickness adipose tissue on abdomen.
• Able to read, understand and sign the Informed Consent Form (ICF).
• Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
• Willing to have limited sun exposure for the duration of the study, including the follow-up period.
• Willing to have photographs and ultrasound measurements taken of the treated area, which could be used de-identified in evaluations and could be used de-identified in presentations and/or publications.
• Female subjects were either post-menopausal, surgically sterilized, or used a medically acceptable form of birth control during the entire course of the study.
• Female subjects with child bearing potential were willing to take a urine pregnancy test and the result must be negative.
• Agreed to maintain their current diet and exercise habits and not be specifically trying to lose weight.

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.