eon™ fr 1064 full abdomen clinical study protocol

Conditions: Abdominal Obesity

Summary: this is a marketing study intended to provide additional data for marketing purposes for the eon™ fr is fda 510(k) which has been cleared for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. this device is intended for individuals with a body mass index (bmi) of 30 kg/m2 or less.


Eligibility criteria:
inclusion criteria: * subject is a healthy male or female \> 18 years or older seeking treatment for unwanted fat in the abdomen. * subject must be able to read, understand and sign the informed consent form (icf) in english. * subject has sufficient thickness (≥ 25 mm) of adipose tissue on the abdomen area. * study subjects must agree to maintain their current diet and weight (not gaining or losing greater than ±5 lbs. * subject must be willing and able to adhere to the treatment and follow-up visit schedule. * subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period. * subject is willing to have photographs and ultrasound measurements taken of the treated area, which will be de-identified in evaluations and may be used in presentations and/or publications. * female subjects must be using medically acceptable form of birth control during the entire course of the study or may be post-menopausal, surgically sterilized. 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.