Eon® Flanks Safety Clinical Study Protocol

Inclusion Criteria:

• Subject is a healthy male or female > 18 years or older seeking treatment for unwanted fat in the flanks.

  • Subject must be able to read, understand and sign the Informed Consent Form (ICF) in English.
  • Subject has sufficient thickness (≥ 20 mm) of adipose tissue on the flanks area.
  • Subject must be willing and able to adhere to the treatment and follow-up visit schedule.
  • Subject is willing to have photographs and ultrasound measurements taken of the treated area.
  • Female subjects must be using medically acceptable form of birth control during the entire course of the study or may be post-menopausal, or surgically sterilized.

Exclusion Criteria:

• • Subject had an aesthetic fat reduction procedure in the treatment area within the previous year

  • Subject was pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in last 6 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.