Device Dossier

Scanning-laser ophthalmoscope/retinal optical coherence tomography system

Device Dossier for Scanning-laser ophthalmoscope/retinal optical coherence tomography system (Scanning-laser ophthalmoscope/retinal optical coherence…

Intended purpose

Ophthalmic Laser Diagnostic Device includes ophthalmic optical coherence tomography system and confocal laser scanning system. Ophthalmic optical coherence tomography system is intended for the in vivo cross sectional and three-dimensional imaging and measurement of ocular tissue, and non-invasive visualisation of ocular vasculature based on OCT angiography (OCTA); confocal laser scanning system is intended for scanning and recording photo and video of fundus. Ophthalmic Laser Diagnosis Device, as a diagnosis device, can assist medical practitioners diagnose ophthalmic diseases.

TGA Public Summary