FDA’s 510(k) Clearance Given to iCare USA’s Eidon Ultra-Widefield Lens Module

October 12, 2021

The FDA has granted 510(k) marketing clearance to iCare USA’s Eidon Ultra-Widefield lens for retinal imaging.

The Raleigh, N.C.-based company says the new lens expands the Eidon platform’s image quality to provide an increased field of view in order to reveal the condition of the periphery of the retina.

The ultra-widefield lens captures 120-degree images of the retina in a single shot or up to 200 degrees using a “mosaic” function, the company said.  

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