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Medical Devices / Submissions and Approvals

FDA Confirms a 510(k) De Novo Path for EyeGate’s Device

Nov. 21, 2016

EyeGate has announced that it plans to pursue a marketing clearance of its EyeGate Ocular Bandage Gel (EyeGate OBG), via the De Novo 510(k) pathway.

The ocular bandage gel is a synthetic biocompatible gel that coats the eye surface and designed to resist degradation under conditions present in the eye.

“We look forward to announcing the top-line data from our PRK pilot study by the end of the year,” the company said. — Cynthia Jessup

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