Device Dossier

Ophthalmic solid-state laser system, photocoagulation

Device Dossier for Ophthalmic solid-state laser system, photocoagulation (Ophthalmic solid-state laser system, Class IIb, sponsor Ellex Medical). ARTG…

Intended purpose

This device is indicated for use in the photocoagulation of both anterior and posterior segments of the eye including: Retinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: proliferative and non-proliferative diabetic retinopathy; choroidal neovascularization; retinal vein occlusion; wet age-related macular degeneration (AMD); retinal tears and detachments; retinopathy of prematurity. Iridotomy, suturelysis and trabeculoplasty in angle closure glaucoma are also indicated.

TGA Public Summary