Norlase Secures FDA 510(k) Clearance and CE Mark for LYNX Pattern Scanning Laser Indirect Ophthalmoscope

Norlase, a global leader in ophthalmic laser technology, has announced the commercial launch of LYNX, the world’s first and only battery-powered pattern scanning laser indirect ophthalmoscope (LIO). With both FDA 510(k) clearance and a CE Mark, LYNX is set to revolutionize retinal treatments by offering portability, efficiency, and advanced features in a compact, untethered design.

A Breakthrough in Ophthalmic Laser Technology

LYNX integrates its laser and pattern module directly into an ergonomic headset, eliminating the need for an external laser source. This innovation allows surgeons to perform treatments virtually anywhere, with unmatched freedom of movement.

Key Features of LYNX

       • Wireless User Interface: Intuitive controls for seamless operation.

       • Multilingual Voice Control: Enhances ease of use during treatments.

       • Battery-Powered Portability: Enables flexibility in treatment locations.

       • Full Pattern Palette: Expands treatment options with advanced laser patterns.

       • simplyCLEAR Safety Filters: Provide enhanced visualization during procedures.

Insights from Leadership

Oliver Hvidt, CEO and co-founder of Norlase, emphasized the importance of efficiency in ophthalmic practice:

“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 mean 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.”

Early User Feedback

LYNX has already received positive reviews from early adopters, including Daniel Diaz from Retina Consultants of Miami:

“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.”

Expanding Accessibility

LYNX marks Norlase’s fourth product launch since 2019, reflecting the company’s ongoing commitment to simplifying ophthalmic practice and enhancing global accessibility to cutting-edge laser technology.

Conclusion

By combining portability, efficiency, and advanced pattern laser capabilities, LYNX sets a new benchmark for laser indirect ophthalmoscopes. With its FDA clearance and CE Mark, LYNX is poised to transform indirect laser treatments, enabling ophthalmologists worldwide to deliver faster, more effective care.