CE Marking Paving the Way for Commercializing the World’s First Light Field Powered Subjective Tele-Refractor in Europe
CHRIST CHURCH, Barbados, March 7, 2024 /PRNewswire/ — Evolution Optiks Limited, a privately held company specializing in light field technology, today announced the CE marking under the European Medical Device Regulation of its Tele-Refractor LFR-260 by its wholly-owned subsidiary Evolution Optiks (Europe) Limited, based in Liechtenstein. This is a major milestone that will enable the company to launch its plans to commercialize the disruptive device in the European Economic Area (EEA) and other CE mark countries. The LFR-260 is intended to be used for distance vision testing to evaluate the visual refractive state of the patient.
Technically, the CE marking indicates that a product complies with all relevant EU directives and regulations concerning health, safety, and environmental protection standards. It is mandatory for a wide range of products, including medical devices, to be marketed in the EEA.
But beyond that, the CE marking is the culmination of a journey that the team of Evolution Optiks began in 2018 when they set out to revolutionize the way eye exams are done. They envisioned a device that would do away with the tedious back-and-forth guessing game patients experience when trying to tell which of the various lenses put in front of their eyes make the letters on the wall chart clearer. The unique QuadView™ of the fully digital LFR-260 shows up to four slightly different prescriptions simultaneously – no lenses or wall chart required. Also, the device was to be usable outside of the doctor’s office or optician’s shop to make eye exams more accessible, more frequent, and affordable. All of this became possible through the proprietary light field technology of Evolution Optiks. The result is a compact, portable device that can be operated remotely from anywhere in the world and provides a modern user experience for patients and practitioners alike.
“While the CE marking allows us to transition to commercialization, we will keep refining our technology and continuously add new features to our LFR-260 refractor, the flagship of our Optokare product line. Through our cloud service and over-the-air updates, our customers can benefit from this ongoing optimization. The recent introduction of an AI framework in particular takes the scope of what a simple eye exam can tell about a patient’s health and wellness to a whole new level”, says Raul Mihali, President & CEO of Evolution Optiks.
“Our sales team will be operating out of our subsidiary in Liechtenstein, which is the perfect hub for the European market, both geographically and economically. It gives us access to all EU and EEA countries as well as Switzerland. Further key location factors are the modern infrastructure and the highly qualified multilingual workforce coming from nearby Austria, Germany, France, Italy, and Switzerland. The planned launch in this large key market will establish a strong foundation for the commercial success and a high market penetration of the LFR-260″, adds Andreas Kusay, Chairman of Evolution Optiks.
The eye and healthcare market abounds with opportunities for a device like the LFR-260. Its key features and capabilities that set it apart from traditional refractors are obvious. The significantly reduced examination time means shorter waiting times and an increased patient throughput. In large optician chains, one qualified optician can serve several outlets remotely. Also, people in underserviced areas get easier access to eye exams.
Founded in 2014, Evolution Optiks Limited is commercializing an extensive and ongoing portfolio of innovation and is on track to revolutionizing how digital information is being 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.
