RELEASE: Norlase Receives FDA 510(k) Clearance and CE Mark Approval for ECHO™ Green Pattern Laser

Ultra-portable footprint and accessible pattern scanning technology.

BALLERUP, Denmark and REDWOOD CITY, Calif., May 8, 2023 /PRNewswire/ -- Norlase, a world-leading manufacturer of ophthalmic lasers developing next-generation laser solutions, today announced both FDA 510(k) clearance such as the CE mark authorization for the ECHO Green Pattern Laser photocoagulator. ECHO is an industry-leading readout and portable laser photocoagulator using MEMS technology. The laser and scanner are fully integrated into a single delivery device that attaches to compatible slit lamps. Other unique features include no external fiber, a wireless user interface, µSec Mode for tissue-conserving treatment, and voice control of patterns and parameters. At an affordable price, ECHO will make pattern scanning technology available to more physicians around the world, giving them the tools to treat efficiently and increase patient numbers.

"ECHO's FDA clearance and CE Mark approval is our most significant milestone to date," said Oliver Hvidt, CEO and co-founder of Norlase. “The launch of ECHO as the first and only truly portable pattern-reading laser brings a new paradigm to ophthalmologists treating conditions of the retina and glaucoma. Our goal has been to develop a pattern laser accessible to all ophthalmologists while maintaining our high level of innovation and precision. ECHO offers all of this in a smart and intuitive product design that allows surgeons to treat with ease.”

Early adopters of the ECHO Pattern Laser have shared positive experiences about the functionality and treatment results of the laser.

"The ECHO laser is easy to use, intuitive and efficient," said Dr. Firas Rahhal, a partner at Retina-Vitreous Associates Medical Group. “It provides excellent power and good absorption, even when used at lower power settings. The visualization of the slit light is excellent, and in one case I treated, this was the case, despite the presence of a significant cataract. Because of these features, along with others such as the easy-to-use display and controls, ECHO is currently the best available slot-lamp-pattern laser I have ever used.”

ECHO is the third product announcement since 2019 and is part of Norlase's series of affordable, portable laser solutions that are rapidly modernizing the way clinicians treat their patients. For more information about ECHO, visit www.norlase.com.

ECHO Pattern Scanning Green Laser includes the functions:

About Norlase: Norlase develops next-generation laser solutions for the treatment of retinal diseases and glaucoma. Founded in Denmark, Norlase is comprised of global industry experts in ophthalmology, laser technology, medical device development and customer care. Norlase's goal is to improve practice efficiency, patient care, and physician convenience for ophthalmologists around the world. Norlase products include LEAF, a laser photocoagulator that is 10 times smaller than existing systems and mounts directly to the slot lamp; LION, the first fully integrated green laser and IOL; and ECHO, the world's first ultra-portable laser pattern reading. Learn more at norlase.com.

Media contact: Levi Hall, levi@lgmarketing.me

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