Norlase Secures FDA 510(k) and CE Mark for LYNX, the World’s First Battery-Powered Pattern-Scanning Laser Indirect Ophthalmoscope
Norlase
Ophthalmic Medical Device Developer
On January 27, 2025, Danish ophthalmic device company Norlase announced its innovative LYNX pattern-scanning laser indirect ophthalmoscope (laser indirect ophthalmoscope，LIO) has obtained FDA 510(k) clearance from the United States and CE certification in Europe. The device has officially been launched in the U.S. and European markets and has begun commercial sales.
LYNX isWorld's First LIO Device with Integrated Pattern Scanning Function，Main Features and Advantages of the LYNX Device:
Innovative Design
LYNX is the world's first and only laser indirect ophthalmoscope (LIO) with integrated pattern scanning functionality. Its laser and pattern modules are integrated into an ergonomic head-mounted device, eliminating the need for an external laser source. This design not only simplifies the structure of the device but also greatly enhances its portability, allowing surgeons to perform laser treatments almost anywhere, free from the constraints of traditional LIO devices that rely on power cords and external consoles.
LIO (Laser Indirect Ophthalmoscope) is a device specifically designed for ophthalmologists to perform fundus examination and treatment. It combines traditional funduscope technology with laser treatment capabilities and is primarily used to treat retinal diseases, especially those located in the peripheral retina. Compared to conventional direct ophthalmoscopes, the LIO provides a wider view of the retina through an indirect perspective, allowing doctors to more clearly observe the overall structure of the fundus.
LIO devices focus a set of small laser beams onto specific areas of the retina to treat various retinal diseases, such as diabetic retinopathy, retinal holes, and retinal detachment, among others. These devices are typically equipped with adjustable light intensity and modes to accommodate different types of treatment needs.
Integrated Technology
LYNX's laser, scanning, and transmission systems are fully integrated into the head-worn device. This innovative design allows doctors to move freely, enhancing efficiency during treatment. The integrated technology makes LYNX lighter and easier to adjust compared to traditional LIO devices, helping doctors maintain greater flexibility during procedures.
Advanced Features
Intuitive Wireless User Interface: LYNX is equipped with an intuitive wireless user interface, simplifying the operation process and enabling doctors to quickly adjust laser parameters and mode settings, improving treatment efficiency.
Multilingual Voice Control: LYNX supports multi-language voice control, allowing doctors to easily adjust modes and parameter settings through voice commands, freeing their hands and enhancing convenience during the treatment process.
Complete Pattern Palette: LYNX offers a full palette of patterns, including 2×2 to 5×5 grids, triple arcs, and circles, meeting various treatment needs.
simplyCLEAR Safety Filter: LYNX is equipped with the simplyCLEAR safety filter, which helps enhance visualization and ensures that ophthalmologists can obtain clear and accurate retinal images during the treatment process.
Portability and Flexibility
LYNX's battery-powered design makes it highly portable. A single charge provides more than a day of usage, allowing ophthalmologists to perform treatments in various settings such as clinics, satellite offices, and operating rooms. Additionally, LYNX's lightweight design and wireless operation enable doctors to switch between different patients more flexibly, significantly improving work efficiency.
Application Field
LYNX is suitable for the diagnosis and treatment of various retinal diseases, especially those located in the peripheral retina. Its main application areas include:
Diabetic Retinopathy (DR): Used for extensive photocoagulation treatment to help slow disease progression.
Retinal Hole and Retinal Detachment: LYNX can accurately perform retinal photocoagulation and repair retinal tears.
Retinopathy of Prematurity (ROP): Used for the treatment of retinopathy of prematurity, preventing further retinal damage.
Peripheral Retinal Diseases: LYNX can provide an extremely wide field of view, aiding in the treatment of peripheral retinal diseases.
NorlaseThe company was founded in 2014, with its headquarters located in Denmark.Focused on developing next-generation laser solutions for the treatment of retinal and glaucoma diseases.Norlase has developed a variety of innovative products:
LEAF: A laser photocoagulator 10 times smaller than existing systems, can be directly mounted on a slit lamp
LION: The First Fully Integrated Green Laser and Indirect Ophthalmoscope
ECHO: The World's First Ultra-Portable Pattern Scanning Laser
LYNX: The World's First Battery-Powered Pattern Scanning Laser Indirect Ophthalmoscope (LIO)
Latest Developments:The company has recently completed an $11 million round of financing, led by London-based West Hill Capital.
Norlase is actively expanding its global distribution network. At the end of 2022, the company announced new distributors in multiple markets across the Americas, Asia-Pacific, Europe, and the Middle East, including Ecuador, Bangladesh, Nepal, Pakistan, Israel, Sweden, and Switzerland.
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