1. Korean Clinical Study:
Objectives:
The objectives of the study were to
demonstrate, confirm, and quantify the
improvements in body contouring and inch
loss.
Summary:
Korean FDA cleared the modifications contained in this submission. 28 subjects (11males and 17 females) in the laser only treatment group experienced an average 2.05cm in reduction. There was also a visual appearance in skin tightening, as well as improved body contouring. 20 subjects treated with both the laser procedure as well as negative pressure experienced a 3.34cm reduction, a 50% improvement with the addition of suction or negative pressure. The medium age of the laser only group was 49, and the laser and suction treatment group's median age was 46. None of the subjects experienced adverse device experience as a result of the treatment.
2. Louisiana State University Study:
Objectives:
To demonstrate, confirm and quantify the improvements in body contouring and
reduction in the appearance in cellulite as evidenced by photography
Summary:
The scientific evidence provided in this article shows that the laser-assisted lipoplasty technique will serve as a valuable contribution to this specific field of medicine and will generate the same expectations as other techniques previously described by other authors. Among its benefits are the reduced risk and improved quality of life for patients. Random samples taken from 12 patients and submitted to scanning electron and transmission electronmicroscopic studies demonstrated that the application of the tumescent technique is an important co-adjuvant to laser beam application because it facilitates beam penetration, and as a result, fat extraction.