Device Dossier
Ophthalmometer
Device Dossier for Ophthalmometer (Ophthalmometer, Class IIa, sponsor Alcon Laboratories). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Ophthalmometer
- Sponsor: Alcon Laboratories
Intended purpose
The device is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.