Nidek Receives FDA 510(k) Clearance for the GYC-500/GYC-500 Vixi Green Scan Laser Photocoagulator
Nidek announced that the FDA has issued 510(k) clearance for the GYC-500/GYC- 500 Vixi Green Scan Laser Photocoagulator. With the clearance, the device is now available in the United States.
The GYC-500/GYC-500 Vixi is a solid state green laser that achieves stable treatment outcomes for multiple applications including retinal photocoagulation, trabeculoplasty, and iridotomy. This multifunction laser is housed in a small console. The 5.7-inch color touchscreen LCD includes an intuitive graphic user interface for quick and easy setup and verification of treatment parameters, according to a company news release.
A wide range of selectable delivery units are available for the GYC-500/GYC-500 Vixi. In addition to conventional single delivery units, scan delivery units are added to a wide range of green laser delivery systems. Incorporating Vixi, scan delivery units, into the GYC-500 enables laser treatments with various scan patterns. The GYC-500 Vixi has 22 preprogrammed scan patterns to allow treatment of varying retinal pathologies, enhancing treatment efficiency and reducing patient chair time.
The user-friendly features and wide range of delivery options incorporated in the GYC-500/GYC-500 Vixi allow versatility for in-office use and the surgical suite, according to Nidek.
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