10.28.20

Norlase Announces FDA Clearance and US Launch of New LION Laser System

Source: Norlase

Norlase announced the 510(k) clearance from the FDA and the immediate commercial launch of Norlase LION, a green laser photocoagulator fully-integrated into a Keeler indirect ophthalmoscope.

Unlike other laser indirect ophthalmoscopes that require a fiber optic connection to a laser source, LION has no fiber tether, is powered by a battery, and utilizes an advanced wireless interface with voice control of parameters, according to Norlase. With the new LION, ophthalmologists can experience an untethered, lightweight, and portable laser treatment solution in practically any setting.

“An FDA clearance and the successful launch of LION are not only gratifying but also validating as we continue to introduce lasers that improve practice efficiency and, most importantly, sets a new standard in eye care,” Oliver Hvidt, CEO and President of Norlase, said in a company news release. “The LION green laser represents our deep commitment to create the highest value for ophthalmologists and the best care for patients. I am extremely proud of our team and excited as we move forward into 2021 with innovative products that shape the landscape of the eye care industry.”

Product features include:

  • Green laser and LIO in one integrated device, eliminating the need for an external laser console.
  • Untethered design with no fiber optic cables, reducing risk of fiber breakage and costly repair experienced by competitive products.
  • Compact and portable design provides easy transport between treatment rooms or offices.
  • Rechargeable battery provides more than a full day of continuous use.
  • Parameter settings operable through an intuitive user interface on a wireless tablet.
  • Optional voice recognition, providing touchless parameter control during treatment.

 “The LION is truly revolutionary,” John Kitchens, MD, Retina Associates of Kentucky, said in the news release. “Being able to do laser so efficiently in any location in a matter of moments has already fundamentally changed our clinic flow. Within a minute or two, I can now laser anyone, safely and reliably, anywhere.”

Dr. S.K. Steven Houston III, Florida Retina Institute, adds: “LION’s superior optics and enhanced visualization has greatly improved the efficiency of my practice. Combined with the portability, I am able to perform retinal laser treatments much faster—which my patients appreciate. This will be a game changer for my practice now and well into the future.”

LION is available and currently being sold in the United States. The company plans to expand adoption of LION and its suite of smart laser solutions in the global retina market.

 

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