(341 days)
The 2RT (LR1532) is indicated for use by a trained ophthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment, in the treatment of; Clinically Significant Macular Edema (CSME) .
2RT (model number LR1532) ophthalmic laser system
This document is a 510(k) clearance letter for the Ellex 2RT ophthalmic laser. It states that the device is substantially equivalent to legally marketed predicate devices for the indication of treating Clinically Significant Macular Edema (CSME) by producing a wound to the Retinal Pigmented Epithelium (RPE) of the retina.
However, the provided text does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or any of the detailed study parameters requested in the prompt. This document is a regulatory approval notice, not a clinical study report.
Therefore, I cannot provide the requested information from the provided text.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.