Vision physiology/eye movement analysis system
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
19-07-2023
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Available from:
Harmony Vision Care Pty Ltd
Class:
Class I
Manufactured by:
Orasis-EAR 12 rue Lacretelle, Paris, 75015 France
Therapeutic area:
65177 - Vision physiology/eye movement analysis system
Therapeutic indications:
A device assembly intended to measure, record and display eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation; it is neither intended to measure dimensional/ocular-shape parameters nor is it dedicated to neurological assessment. It includes visual stimuli (light patterns) and a tracking device (cameras)
Authorization status:
A
Authorization date:
2023-03-14
