CE marking: The Lipotherme laser is intended to be used for lipomes and gynecomastia treatment. 

FDA: The intended use of Lipotherme device is Laser Assisted Lipolysis. This laser assisted lipolysis device is only intended to be used on a small treatment area.  A  small  treatment  area  is  a  small  anatomical  site  such  as  the  chin  or  upper arms (triceps) that is treated to remove a total of about 120cc of fat per anatomic site.

The safety and effectiveness of laser assisted lipolysis on larger areas and laser assisted lipolysis procedures with liquefied fat remaining in the body or as an adjunct or  pre-treatment for standard  liposuction procedures have not been  evaluated cleared by the FDA. The FDA has not evaluated clinical data demonstrating the safety and effectiveness of this device for larger volumes or areas of fat treatment such as thighs, buttocks, or abdomen.