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FDA Grants 510K clearance to LipoControl Laser Lipo Device

 

New laser lipo device from Osyris gives physicians greater energy control.

Osyris Medical announced today that it has received clearance from the FDA for its LipoControl system for laser lipo Like other laser lipo units, the device is used to melt fat with a laser making it easier to suction out and stimulating collagen in the heating process so that skin tightening is improved.

LipoControl fda clearance
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LipoControl builds on Osyris' original LipoTherme design, by adding an energy monitoring device to ensure uniform delivery throughout the procedure. Dr. Neil Sadick of Sadick Dermatology, who was involved with the testing of the LipoControl system says he's seen positive results with the new device. As Dr. Sadick describes, LipoControl "has a computer tracking system that allows you determine in real live time exactly how much energy is being delivered to a given area in the body.... It's almost like seeing inside the body where the liposuction or laser fiber is, allowing the physician to deliver a uniform amount of energy."

Dr. Sadick said that upon reaching the ideal energy output, the screen turns green to indicate to the physician that he need not go any higher. This extra safety will reduce the number of burns sometimes reported with other devices.

Other laser lipo procedures don't offer this monitoring technology. According to Dr. Sadick, "With other laser lipolysis technologies you're randomly moving laser fiber in and out. In our controlled FDA studies, we found that the pattern of uniform energy delivery is much more homogeneous when you can actually have a tracking device that allows you to determine when an even or desired amount of energy is being deposited in a given surface area of the body."

In a press release, Philippe Rochon, Vice President of R&D for Osyris Medical stated, "We are glad to bring this new device into the US market. In the current regulatory framework, in which several manufacturers are facing difficulties in the 510(k) process, the clearance of such innovating product tends to emphasize the technological breakthrough made by Osyris Medical with the LipoControl."