| Eligibility |
Inclusion Criteria:
1. Able to read, understand and voluntarily provide written informed consent.
2. Healthy male or female, = 18 years of age seeking treatment for unwanted fat in the
flanks and or abdomen
3. BMI score is less than 35.
4. Able and willing to comply with the treatment/follow-up schedule and requirements.
5. Women of child-bearing age are required to be using a reliable method of birth control
at least 3 months prior to study enrollment and for the duration of the study, and
have a negative Urine Pregnancy test at baseline.
Exclusion Criteria:
1. Pregnant, intending to become pregnant, postpartum or nursing in the last 6 months.
2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the
treatment area in the past 12 months.
3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV
infection) or use of immunosuppressive medications, 6 months prior to and during the
course of the study.
4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or
excessive bleeding.
5. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted),
anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of
treatment.
6. Having a history of skin cancer or any other cancer in the areas to be treated,
including presence of malignant or pre-malignant pigmented lesions.
7. Having a permanent implant in the treatment area such as metal plates or an injected
chemical substance such as silicone or parenteral gold therapy (gold sodium
thiomalate).
8. Use of medications, herbs, food supplements, and vitamins known to induce
photosensitivity to light exposure at the wavelength used or history of
photosensitivity disorder.
9. 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.
10. Tattoos in the treatment area.
11. Poor skin quality (severe laxity).
12. Abdominal wall, muscular abnormality or hernia on physical examination.
13. Use of retinoids such as oral isotretinoin (Accutane™) within the past six months or
during course of the study.
14. History of keloid or hypertrophic scar formation or poor wound healing in the
treatment area.
15. As per the investigator's discretion, any physical or mental condition which may make
it unsafe for the subject to participate.
16. Unable or unlikely to refrain from sun exposure, artificial tanning, including the use
of tanning booths, prior to (six weeks) and during the course of the evaluation.
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