Optos receives 510K clearance for ultra-widefield angiography system

New Orleans-Optos received 510K marketing clearance from the FDA for the Optos P200A Ultra-Widefield Scanning Laser System.

The image generated by the device, Optos Angiomap, provides diagnostic information across approximately 200 degrees of internal viewing angle of the retina. This advanced angiography test enables the retinal specialist and comprehensive ophthalmologist to view the extent of peripheral disease progression in a unique way; customize therapy to each patient's diagnosis; view retinal landmarks that facilitate therapy; and provide a unique ability to document and monitor post-treatment efficacy in the peripheral retina.

The Optos Panoramic200A contains three lasers that provide red, green, and blue wavelengths. The instrument is capable of producing the current red/green color and monochromatic Optomap image, but with the addition of a blue laser and enhanced software, the instrument is capable of angiography as well. The angiographic mode will allow capturing a sequence of ultra-wide field retinal images as fluorescein dye flows through the retinal vessels.

"With the addition of the Optos Angiomap and P200A, Optos is expanding its product line into high-resolution angiography with the unique ability to perform high-resolution documentation of retinal disease in the far periphery as well as the central pole. This may prove to be very important in diabetic diagnosis and treatment, as well as in managing other diseases where peripheral retinal condition is, or proves to be, important," said Stephane Sallmard, chief executive officer, Optos.

This system will be available for general use in the coming months.