YOLO Medical Inc, an industry leader in the manufacturing and distribution of medical and aesthetic devices, received clearance from US FDA for marketing its new generation body contouring laser system, Lipofina.
YOLO has completed its second-generation low-level laser device for body contouring, creating and revolutionising new cutting edge advancements to our patented technology while continuing to push the envelope of evolution with dramatic results. This laser system will ensure greater consistent results, new safety features and added flexibility of treatment parameters.
"The Lipofina laser will undoubtedly raise the bar in the market", states Robert J Krznaric, CEO of YOLO Medical Inc. "We feel our company has always had the best in class laser, as confirmed by our loyal customer base. The Lipofina will define and set a new standard in this industry for years to come and will now give our customers two best in class options to choose from, the established YOLO Curve and now the Lipofina".
Over the past 1.5 years, YOLO completed a randomised double blind controlled study to evaluate the effectiveness and safety of the Lipofina. The study results showed that a staggering 95 per cent of subject that were treated with the Lipofina reached and surpassed the primary end point compared to 0 per cent on the sham device (95 per cent vs. 0 per cent; P <.0001).
"We knew this device was special; the study result were statistically significant, validating all the hard work that was put into this laser over the past 4 years", states Robert J Krznaric. "Now that we have clearance to market the Lipofina, our focus will be on launching this device and providing our customers with the most technologically advanced device in the market. Currently we are anticipating a launch date in the first quarter of 2016".
Lipofina features include: An advanced communication protocol that ensures all paddles are in constant two-way communication and are continually monitored over the course of a treatment; Thermoregulation Technology to ensure the diodes performing optimally throughout each treatment; A Sophisticated Temperature Control Technology (TCT) that monitors laser functionality to ensure optimal laser light is delivered.
YOLO Medical Inc. is a Canadian-based company dedicated to excellence in the design, research and development, manufacturing, distribution and support of innovative medical devices that are scientifically superior and results-driven. A recognized and trusted primary provider of medical and aesthetic solutions, YOLO empowers consumers to achieve their overall health, wellness and aesthetic goals.