Device Dossier

Spectral-domain optical coherence tomography system

Device Dossier for Spectral-domain optical coherence tomography system (Spectral-domain optical coherence tomography system, Class IIa, sponsor Alcon…

Intended purpose

Unity DX device is a non-contact ophthalmic imaging and analysis device. It is indicated for visualisation and measurement of ocular structures and their optical properties, including the cornea, anterior chamber, iris/pupil, crystalline lens, vitreous and retina.

TGA Public Summary