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

USA - English

• USA - English

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.

"Today's FDA approval of our tele-refractor marks a pivotal moment in our company's young history. We are thrilled to see the hard work and dedication of our R&D team come to fruition. Our thanks go to the investigators and participants of the study, our advisors, our entire staff and our shareholders whose joint efforts have made this achievement possible", says Raul Mihali, President & CEO of Evolution Optiks. "While we will take a moment to celebrate this major milestone, we are eager to further explore the enormous potential of our light field technology which goes well beyond the healthcare sector."

"With both FDA approval and CE mark in hand, we are gearing up for the product launch of the LFR-260. With a combined population of close to 800 million people, the US and the European Economic Area are core markets with rapidly growing healthcare sectors which offer abundant opportunities for forward-looking products and technologies. The flagship of our Optokare line is set to stir up the market and is a strong candidate to become the standard of modern refraction", comments Andreas Kusay, Chairman of Evolution Optiks.

"Industry experts tell us that this technology will revolutionize eye care. Specifically, being able to see comparable eye prescriptions simultaneously will eventually render existing refraction methods obsolete. A more precise eye prescription is not only about the optical precision of an instrument, but also about helping practitioners navigate the many subjective factors involved in an eye exam. Even the voice and tone of an examiner can influence patients' decisions on what they see better. With our differentiated light field technology, we can address many existing limitations and go beyond - including applying AI extensively. It redefines what's possible in healthcare", adds John Jacobsen, VP of Product.

Founded in 2014, Evolution Optiks Limited is commercializing an extensive and ongoing portfolio of innovation and is on track to revolutionizing how digital light is being created and consumed. The company's primary categories of interest are optometry instruments, neuro-optical screening and training devices and, more broadly, it is exploring solutions based on vision-adapted, multi-view and light field displays, with applications in medicine, consumer solutions, advertising and media, automotive and avionics.

SOURCE Evolution Optiks