Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser (Flanks)
Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser (Flanks)
The objective of this clinical study is to assess the safety and efficacy of using a 1060 nm
 diode laser for non-invasive fat reduction of the flanks.
Open-label, baseline-controlled, evaluator-blind, multi-center study evaluating a 1060 nm
 diode laser for non-invasive fat reduction of the flanks. The study will enroll up to 50
 subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single
 study treatment. Subjects will be followed at six weeks and twelve weeks post-treatment.
 Twelve week outcome will be compared to baseline.
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