FDA Approves Multicolor Pattern Scan Laser for Eye Surgery

Yael Waknine

August 30, 2011

August 30, 2011 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a multicolor pattern scan laser photocoagulator (MC-500 Vixi, NIDEK Co, Ltd), the first pattern scan laser that allows eye surgeons to choose the best color or combination of colors when treating various ocular pathologies.

The device supports the most popular wavelengths (532 nm green, 577 nm yellow, and 647 nm red). Green is most often used for treating retinal pathology, whereas yellow is the wavelength of choice for lesions close to the macula, and red is used for photocoagulation of deep choroidal pathology.

"This pattern scan laser based on our previous successful technology is our most advanced laser yet, finally offering the choice of any configuration of Green, Yellow, or Red colors," said Motoki Ozawa, president and chief executive officer of NIDEK, in a company news release. "This new scanning system demonstrates our continued commitment to the ophthalmic community."

Other features include 14 preprogrammed scan patterns including arc, triple arc, circle, curve, square, triangle, line, macular grid, and single spot. An easy-touch screen allows the spot spacing for each pattern to be changed and the pattern rotated in 15° increments, and spot size is continuously variable from 100 to 500 μm (50 - 500 μm in single mode), enabling eye surgeons to compensate for retinal changes resulting from laser contact lenses. The 4 most frequently used scan patterns can be saved and recalled by a single touch of the liquid crystal display menu.

Three different modes of operation are available: Single mode is used for conventional laser emission, auto-manipulation mode offers repeated laser emission with variable interval times and conventional coagulation settings in the selected scan pattern, and scan mode is for repeated laser emission with a fixed interval time, high power, and instantaneous speed.

The device also offers a 60% reduction in power consumption relative to the company's previous model (MC-500). "This energy saving is one of many examples of NIDEK's commitment to global environmental protection," the company notes on its Web site.

The new laser was introduced at the American Society of Retina Specialists 29th Annual Meeting.