Norlase announced that it has been granted the CE Mark approval for the LEAF, a first in class, fiberless green laser for the treatment of retina and glaucoma diseases. The CE Mark follows the recent FDA 510(k) market clearance of the LEAF and ISO 13485:2016 certification of Norlase’s medical device and quality management system.
“CE Mark approval allows Norlase to market and distribute LEAF in the European Union and many other countries who recognize the European standard,” Oliver Hvidt, CEO and President of Norlase, said in a company news release. “This marks another significant milestone as we continue our mission to improve practice efficiency and workflow for ophthalmologists and equip them with the tools to provide quality eye care for patients worldwide.”
LEAF is a green laser photocoagulator that allows ophthalmologists to perform laser therapy in almost any exam room, with minimal set-up time and physical space required. The entire laser unit attaches to an existing slit lamp, eliminating the need for a cart or counter space to house the laser console. The device’s fiberless design reduces costly service repairs common with other laser technology, according to Norlase.
LEAF utilizes a wireless tablet as the user interface. An optional voice control feature provides touchless parameter control during treatment, allowing the physician to maintain focus on the patient.
“The LEAF is a next-generation laser. Norlase has provided a solution for a more streamlined treatment station that ophthalmologists will appreciate over traditional lasers. From the sleek ultra-compact design free of cumbersome external fibers, to the meticulously thought out features, like voice control, and an affordable price point, LEAF is a no-brainer and fits seamlessly into any practice,” said Greg Fava, VP Medical Devices of Norlase.