Norlase Receives FDA 510(k) Clearance and CE Mark for LYNX Pattern Scanning Laser Indirect Ophthalmoscope
Norlase announced the FDA 510(k) clearance and CE Mark for Norlase LYNX, which the company describes as the world’s first and only pattern scanning laser indirect ophthalmoscope.
Commercially available now, the LYNX is battery-powered and provides surgeons the ability to treat virtually anywhere. According to Norlase, the laser and pattern module is built into an ergonomic headset, which eliminates the need for an external laser source. Surgeons can move freely and efficiently during treatment with features such as an intuitive wireless user interface and multilingual voice control.
“The most important resource for today’s ophthalmologists is time,” Oliver Hvidt, CEO and Co-Founder of Norlase, said in a company news release. “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 5 years and a testament to our ongoing mission to simplify ophthalmic practice, while maximizing efficiency and comfort.”
LYNX Pattern Scanning LIO features include:
- Laser, scanner, and delivery system are fully integrated in the ultralight headset
- Battery-powered for portability and treatment flexibility
- Full pattern palette includes 2×2 to 5×5 grids, triple arcs, and circles
- simplyCLEAR safety filters for enhanced visualization
- Multilingual voice control of patterns and parameters
View EyewireTV's coverage of the commercial launch of the LYNX device here.