LED Device for Non-Invasive Lipolysis

Exclusion Criteria

• •Pregnant, expectation of pregnancy, postpartum or nursing (\<6 months).
• •History of skin disease in the area to be treated over the last 6 months.
• •Previous surgical intervention to the treatment area.
• •History of skin cancer or pre-cancerous lesions at the treatment areas.
• •Having any electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
• •History of immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
• •Uncontrolled systemic diseases such as diabetes.
• •Active infections in the treatment area.
• •History of dysplastic nevi.
• •Significant concurrent skin conditions or any inflammatory skin conditions.
• •Active herpes simplex infections (e.g. cold sores), open lacerations or abrasions in the treatment area.
• •Chronic or cutaneous viral, fungal, or bacterial diseases.
• •Use of Accutane™ (Isotretinoin) within the past six months.
• •Keloid or hypertrophic scar formation in the treatment area.
• •Tattoos in the treatment area.
• •History of auto-immune disorders.
• •Erythema abigne, when identified treatments should be discontinued.
• •History of photosensitivity disorder that can be exacerbated by laser or intense light.
• •Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light.
• •History of poor wound healing in the treatment area.
• •Sunburns.
• •Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a month) and during the course of the evaluation.
• •Prior skin treatment with laser or other devices on the same treatment area within the last six months prior to study enrollment or during the course of the study.