Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction

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.
• BMI score is less than 35. 4. 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 enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.

Exclusion Criteria

• 1. 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 months prior to and during the course of the study.
• History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
• Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment.
• 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.
• 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).
• Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or 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. 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.
• History of keloid or hypertrophic scar formation or poor wound healing in the treatment area.
• As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
• 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.