FDA submits 510(k) approval of iCare USA’s EIDON Ultra-Widefield Lens module

The EIDON Ultra-Widefield Lens module from iCare USA has received 510(k) approval from the FDA for distribution in the US.

The Ultra-Widefield lens enables infrared, autofluorescence and fluorescein angiography images with up to 200° panoramic view. The lens captures 120 degree images of the retina in a single shot or up to 200 degrees with the “Mosiac” feature. This shows small details, highlighting signs of pathology from the center to the periphery and enables EIDON diagnostics to surpass limitations of conventional diagnostic tools.

The EIDON from iCare is the first TrueColor Confocal system to combine standard fundus imaging with features of Scanning Laser Ophthalmoscopy (SLO) systems. The retinal imaging system provides widefield views in multiple imaging modalities.

The Ultra-Widefield lens can be retrofitted to most of the EIDON fundus imaging systems.

iCare offers clinicians ophthalmic diagnostic tools to detect glaucoma, diabetic retinopathy and age-related macular degeneration (AMD). Their portfolio includes automated TrueColor imaging devices, perimeters and handheld rebound tonometers.

More information about the EIDON Ultra-Widefield lens can be found on the iCare website.

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