Spectral-domain optical coherence tomography system
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
22-01-2021
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Available from:
Cylite Pty Ltd
Class:
Class I
Manufactured by:
Cylite Pty Ltd 300 Wellington Road, Mulgrave, VIC, 3170 Australia
Therapeutic area:
58850 - Spectral-domain optical coherence tomography system
Therapeutic indications:
The HP-OCT? Instrument is intended for non-contact measurement and visualization of ocular structures including the cornea, anterior chamber, iris/pupil, crystalline lens and retina. The measurements of biometric parameters such as corneal curvature, cornea thickness, chamber depth, lens thickness, axial length and white-to-white (WTW) distance are used to assist in the determination of the appropriate power and type of intraocular lens.
Authorization status:
A
Authorization date:
2020-11-20
