Device typeScanning-laser retinal imaging system: An assembly of electrically-powered ophthalmic instruments and digital image capturing/processing devices intended to use a low power laser beam to scan in two dimensions over the retina and detect the reflected (or returned) light to generate and capture digital confocal images of the fundus. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). It is typically used for assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of choroiditis.
FDA categoryOphthalmoscope,Laser,Scanning
Device ID05057056106502
Catalog numberA10650
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information