Norlase Receives FDA 510(k) Clearance and CE Mark for LYNX™ Pattern Scanning Laser Indirect Ophthalmoscope
Introducing the World's First LIO with Integrated Pattern Scanning Capabilities
BALLERUP, Denmark and REDWOOD CITY, Calif., Jan. 27, 2025 /PRNewswire/ -- Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, today announced the immediate commercial launch and FDA 510(k) clearance and CE Mark for Norlase® LYNX™, the world's first and only pattern scanning laser indirect ophthalmoscope. LYNX is battery-powered and provides surgeons an untethered laser solution that empowers them to treat virtually anywhere. The laser and pattern module is built into the ergonomic headset, which eliminates the need for an external laser source. Surgeons can now move freely and efficiently during treatment with advanced features like an intuitive wireless user interface and multilingual voice control offering surgeons more options to streamline their treatment flow.
"The most important resource for today's ophthalmologists is time," said Oliver Hvidt, CEO and Co-Founder of Norlase. "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 maximizing efficiency and comfort."
Early adopters of the LYNX Pattern Scanning LIO share positive feedback about the laser.
"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," said Dr. Daniel Diaz, Retina Consultants of Miami. "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."
Norlase continues its pattern of innovation with LYNX, the company's fourth product announcement since 2019. Similar to its predecessors, LYNX is ultra-compact, portable, and affordable, and aims to make cutting-edge laser technology more accessible to ophthalmologists worldwide.
Notable LYNX Pattern Scanning LIO features:
- Laser, scanner, and delivery system are fully integrated in the ultralight headset
- Battery-powered for portability and treatment flexibility
- Full pattern palette includes 2x2 to 5x5 grids, triple arcs, and circles
- simplyCLEAR safety filters for enhanced visualization
- Multilingual voice control of patterns and parameters
About Norlase
Norlase develops next-generation laser solutions for the treatment of retina and glaucoma diseases. Founded in Denmark, Norlase is made up of worldwide industry experts in ophthalmology, laser technology, medical device development, and customer care. Norlase is on a mission to improve practice efficiency, patient care, and physician convenience for ophthalmologists worldwide. Norlase products include LEAF, a laser photocoagulator that's 10x smaller than existing systems and mounts directly on the slit lamp; LION, the first fully integrated green laser and LIO; ECHO, the world's first ultra-portable pattern scanning laser; and LYNX, the world's first fully-integrated pattern LIO. Learn more at norlase.com.
SOURCE Norlase
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