Norlase receives FDA clearance, CE Mark approval for portable scanning laser photocoagulator

(Image Credit: AdobeStock/rohane)

Norlase announced it has received both FDA 510(k) clearance and CE Mark approval for the ECHO Green Pattern Laser photocoagulator.

According to the company, ECHO is a portable scanning laser photocoagulator utilizing MEMS technology. The laser and scanner are completely integrated into a single delivery device that attaches to compatible slit lamps.

The company noted in a news release features include no external fiber, a wireless user interface, µSec Mode for tissue-sparing treatment, and voice control of patterns and parameters. With an affordable price point, ECHO will make pattern scanning technology accessible to more doctors worldwide, equipping them with the tools to treat efficiently and increase patient throughput.

Oliver Hvidt, CEO and co-founder of Norlase, noted the FDA clearance and CE mark approval of ECHO mark the company’s most significant milestone to date.

“The launch of ECHO as the first and only truly portable pattern scanning laser brings a new paradigm to ophthalmologists that treat retina and glaucoma conditions,” Hvidt said in the news release. “Our goal has been to develop a pattern laser that is accessible to all ophthalmologists, while maintaining our high level of innovation and precision. ECHO provides all of this in a smart, highly-intuitive product design enabling surgeons to treat with ease.”

Early adopters of the ECHO pattern laser, including Firas Rahhal, MD, a partner in Retina-Vitreous Associates Medical Group in Los Angeles, have shared positive experiences about the laser’s functionality and treatment results.

“The ECHO laser is easy to use, intuitive and efficient,” Rahhal said in the news release. “It provides excellent power and good uptake, even when used at lower power settings. The visualization on the slit lamp delivery is excellent, and in one of the cases I performed, this was true despite the presence of significant cataract. Due to these characteristics, along with others like the easy-to-use screen and controls, the ECHO is currently the best available slit lamp pattern laser that I’ve used.”

ECHO is the company’s third product announcement since 2019, and is part of Norlase’s series of portable and affordable laser solutions.