Norlase has received the US Food and Drug Administration (FDA) 510(k) approval and the CE mark for its LYNX pattern scanning laser indirect ophthalmoscope (LIO).
In addition to the regulatory approvals, the Denmark-based ophthalmic medical devices company plans to commercially launch its LYNX pattern scanning laser immediately.
LYNX is a battery-powered LIO device designed to provide surgeons with an untethered laser solution that enables treatments in virtually any setting.
The device incorporates laser and pattern modules directly into its ergonomic headset, eliminating the need for an external laser source.
Also, it comes with advanced features, such as an intuitive wireless user interface and multilingual voice control to allow surgeons to move freely during treatment.
Norlase CEO and co-founder Oliver Hvidt said: “The most important resource for today’s ophthalmologists is time. That’s why they’ve been asking for pattern LIO ever since the invention of pattern lasers more than 15 years ago.
“With LYNX, pattern LIO is finally here. Faster LIO treatments means less ergonomic stress, more quality time with patients and more practice days that end on time. I’m extremely proud of our team and thankful to the doctors who helped guide the development.
“LYNX is our fourth product launch in just five years and a testament to our ongoing mission to simplify ophthalmic practice, while maximising efficiency and comfort.”
According to Norlase, LYNX is its fourth product launched since 2019 and comes with an ultra-compact, portable, and affordable design, similar to its predecessors.
The LIO features a full pattern palette that includes 2×2 to 5×5 grids, triple arcs and circles, simplyCLEAR safety filters for enhanced visualisation, and multilingual voice control.
Also, early adopters of the LYNX pattern scanning LIO share positive feedback, said Norlase.
Retina Consultants of Miami Daniel Diaz said: “This innovative device combines the speed and efficiency of pattern laser technology with unmatched portability and comfort, setting a new standard for indirect laser treatments.
“The device’s portability and robust laser pattern options make it a cutting-edge tool that has significantly improved the pace and quality of my retina treatments.”
