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

Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields, and vacuum-assisted radio frequency for non-invasive fat reduction of the abdomen and flanks. The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive 3 study treatments of the diode laser and 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency. Subjects will be followed at twelve weeks post-final diode treatment. The twelve-week post-treatment outcome will be compared to the baseline.

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.