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Evolution Optiks Receives U.S. FDA 510(k) Clearance for Breakthrough Eye Examination Device 

CHRIST CHURCH, Barbados, June 4, 2024 /PRNewswire/ -- Evolution Optiks Limited, a privately held company specializing in light field technology, today announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LFR-260, the world's first light field powered subjective tele-refractor. This is the second regulatory clearance for the device after obtaining the European CE mark in March 2024.

The FDA’s approval was based on the results of a multi-center, open-label, 2×2 cross-over study with 108 patients who underwent a full routine eye examination. To differentiate the device from traditional Class I 510(k) exempt manual refractors, the agency has created a new product category that better reflects the unique approach offered by a light field-based refractor.

The LFR-260 is a compact, portable, fully digital device that can be operated remotely from anywhere in the world via tablet which makes it ideal for telemedicine. Its integrated micro lens arrays and ultra-high pixel density displays enable it to generate ray-traced, multi-focal optotypes, in real-time, making dedicated refraction rooms, wall charts, and back-and-forth changing of physical lenses a thing of the past. The proprietary QuadView™ technology can show multiple slightly different prescriptions at the same time, allowing patients to make a purely vision-based subjective decision, without interference or influence from the practitioner.

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