| Eligibility |
Inclusion Criteria:
- able to read, understand and voluntarily provide written informed consent
- healthy male or female > 18 years of age seeking treatment for unwanted fat in the
abdomen
- BMI score is less then 30
- agree to not making any major changes in their diet or lifestyle during the course of
the study
- able and willing to comply with the treatment / follow up schedule and requirements
- women of child-bearing age are required to be using a reliable method of birth control
at least 3 months prior to study enrolment and for the duration of the study, have a
negative urine pregnancy test baseline
Exclusion Criteria:
- pregnant in the last 3 months intending to become pregnant, postpartum or nursing in
the last 6 months
- any previous liposuction / lipo-sculpture or any type of surgical procedure in the
treatment area in the past 12 months
- history of immunosuppression / immune deficiency disorders including AIDS and HIV
infection, or use of immunosuppressive medications, 6 month prior to and during the
course of the study
- History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive
bleeding
- Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted),
anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of
treatment
- Having a history of skin cancer or any other cancer in the area to be treated,
including presence of malignant or pre-malignant pigmented lesions
- Having a permanent implant in the treatment area such as a metal plate or injected
chemical substance such as silicone pr parenteral gold therapy (gold sodium
thiomalate)
- Use of medications, herbs or food supplements and vitamins known to induce
photosensitivity to light exposure at the wavelength used history of photosensitivity
disorder
- Suffering from significant skin conditions in the treatment area or inflammatory skin
conditions including but not limited to open lacerations, abrasions, herpes sores,
cold sores, active infections
- Tattoos in the treatment area
- Poor quality skin (laxity)
- Abdominal wall, muscular abnormality or hernia on physical examination
- Unstable weight within the last 6 months (+ or - 3% weight change in the prior six
months)
- Participation in another clinical study involving the same anatomical areas within the
last 6 months
- History of keloid and hypertrophic scar formation or poor wound healing in the
treatment area
- As per the investigators discretion any physician or mental condition which may make
it unsafe for the subject to participate
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