LFR-260 tele-refractor receives FDA clearance
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The FDA cleared the LFR-260, a light field powered subjective tele-refractor, Evolution Optiks announced in a press release.
“[The] FDA approval of our tele-refractor marks a pivotal moment in our company’s young history,” Raul Mihali, president and CEO of Evolution Optiks, said in the release.
The LFR-260 is a compact and portable digital device that can be operated via tablet, with integrated micro lens arrays and ultra-high pixel density displays to generate ray-traced, multifocal optotypes in real time. It uses proprietary QuadView technology to show slightly different prescriptions at the same time.
This marks the second regulatory clearance for the LFR-260, which received the CE mark in Europe earlier this year.
“With both FDA approval and CE mark in hand, we are gearing up for the product launch of the LFR-260,” Andreas Kusay, chairman of Evolution Optiks, said in the release. “With a combined population of close to 800 million people, the U.S. and the European Economic Area are core markets with rapidly growing health care sectors [that] offer abundant opportunities for forward-looking products and technologies.”
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