Light field technology-focused company Evolution Optiks has secured the US Food and Drug Administration (FDA) 510(k) clearance for its LFR-260 eye examination device.
The LFR-260, a compact and fully digital device, is portable and can be remotely controlled via a tablet from anywhere in the world. This makes the device particularly suitable for telemedicine applications.
It is claimed to be the world’s first light field-powered subjective tele-refractor.
The latest regulatory clearance for LFR-260 follows its European CE mark, which was obtained in March 2024.
The eye examination device is equipped with micro lens arrays and pixel density displays for real-time generation of ray-traced, multi-focal optotypes.
Evolution Optiks said that the proprietary QuadView technology used in the device enables the display of multiple slightly different prescriptions simultaneously. This empowers patients to make vision-based subjective decisions independently, free from practitioner interference or influence.
Evolution Optiks president and CEO Raul Mihali said: “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.
“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.”
The FDA clearance for the LFR-260 device has been driven by the findings from a multi-centre, open-label, 2×2 cross-over trial. It involved 108 patients undergoing full routine eye examinations.
The US health agency has introduced a new product classification to recognise the approach of a light field-based refractor. This category will differentiate the device from traditional Class I 510(k) exempt manual refractors, said Evolution Optiks.
Established in 2014, Evolution Optiks is focused on optometry instruments, neuro-optical screening, and training devices. In particular, the company is exploring solutions centred around vision-adapted, multi-view, and light field displays.
