Device typeOphthalmic laser system beam guide: A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.
FDA categoryINSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED, Laser, ophthalmic
Device ID00632307002151
AvailabilityPrescription
Single useYes
SterileYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information
Size20 Gauge Needle
Needle Gauge20 Gauge