Evolution Optiks Receives FDA 510(k) Clearance for LFR-260 as the First Light Field Powered Subjective Tele-Fractor

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The FDA has granted 510(k) clearance to Evolution Optiks Limited for its LFR-260 tele-refractor, which has been labeled as the first light field powered subjective tele-refractor. According to the company, this marks the second regulatory clearance for LFR-260, after initially receiving clearance in Europe earlier this year in March.¹

"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," said Raul Mihali, president, CEO, Evolution Optiks, in a press release. "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."

FDA clearance for the LFR-260 was based on the successful results of a multi-center, open-label, 2×2 crossover study consisting of 108 patients who underwent a full routine eye examination. In order to showcase the device’s capabilities, the FDA has created a new product category specifically for light field-based refractors.

The LFR-260 is a digital device that can function remotely via tablet, making it sufficient for telemedicine applications. Its features include integrated micro lens arrays and high-density displays, enabling real-time generation of multi-focal optotypes. As a result, it doesn’t require traditional refraction equipment and facilitates a purely vision-based decision-making process for patients.¹

"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," said Andreas Kusay, chairman, Evolution Optiks, in the press release.

The LFR-260 was previously cleared for CE marking under the European Medical Device Regulation. This specifies that the product is in line with all EU directives and regulations concerning health, safety, and environmental protection standards, which is required for marketing in the region.

Evolution Optiks states that at the time of its launch, the primary goal was to create a device that would eliminate patient confusion associated with attempting to determine which letters are on a chart when being tested through various lenses, shaking up the process of eye exams in the process. The QuadView, which is a part of its LFR-260 technology, presents up to four slightly different prescriptions simultaneously—no lenses or wall chart required.²

"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," said John Jacobsen, VP, product, Evolution Optiks, in the press release.

References

1. Evolution Optiks Receives U.S. FDA 510(k) Clearance for Breakthrough Eye Examination Device. PR Newswire. June 4, 2024. Accessed June 6, 2024. https://www.prnewswire.com/news-releases/evolution-optiks-receives-us-fda-510k-clearance-for-breakthrough-eye-examination-device-302162715.html

2. Evolution Optiks Secures CE Marking for Groundbreaking Eye Care Device. PR Newswire. March 7, 2024. Accessed June 6, 2024.