A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia Obesity Laser on the Reduction of Circumference of the Hips, Waist and Upper Abdomen for Individuals With a Body Mass Index (BMI) of 30 to 40 kg/m2

The American Society of Plastic Surgeons (ASPS) 2011 report states that the market for cosmetic procedures has shown significant growth over the past two years, with 13.8 million cosmetic plastic surgery procedures performed in the United States in 2011, up 5% since 2010. While surgical cosmetic procedures did increase significantly from 2010 to 2011, the overall growth in cosmetic procedures is being primarily driven by a substantial rise in minimally-invasive procedures. Cosmetic minimally-invasive procedures increased 6%, with nearly 12.2 million cosmetic minimally-invasive procedures having been performed in 2011. This highlights the growing consumer demand for non- or minimally-invasive cosmetic procedures that do not involve surgical procedures such as liposuction and the associated risks, potential complications and lengthy and painful recovery processes. Low level laser light therapy, such as that to be provided through application of the Erchonia® Obesity Laser in this clinical study protocol, offers a simple, non-invasive, safe, effective and side-effect free alternative to achieving body circumference reduction. Justification for this assertion of anticipated safety and effectiveness of the application of the Erchonia® Obesity Laser for the reduction of body circumference is found through three FDA clearances for Erchonia® Low Level Laser devices for body circumference reduction indications, as follows: K123237 (532 nm green light diodes): Erchonia® Zerona™ 2.0 Laser: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs. K121695 & K082609 (635 nm red light diodes): Erchonia® ML Scanner (MLS) & Erchonia® Zerona: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs. K121690 & K120257 (635 nm red light diodes): Erchonia® MLS, Zerona, Zerona-AD: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of the upper arms. Therefore, Erchonia low level lasers have been determined safe and effective by the FDA for application for body circumference reduction indications for multiple body areas, such that evaluation of application of the Erchonia Obesity Laser to reducing body circumference in more overweight individuals is a natural extension of its proven and accepted application for body circumference reduction purposes.