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Norlase receives FDA 510(k) clearance and CE Mark approval for laser photocoagulator
The scanning laser features a wireless user interface, no external fiber and utilizes MEMS technology.
Norlase said in a press release the laser and scanner are integrated into a single delivery device that attaches to compatible slit lamps. (Image courtesy of Adobe Stock/Nejron)
Norlase this week announced it has received both FDA 510(k) clearance and CE Mark approval for its ECHO Green Pattern Laser photocoagulator.
According to a company news release, the new technology is a portable scanning laser photocoagulator utilizing MEMS technology. The laser and scanner are integrated into a single delivery device that attaches to compatible slit lamps.
The laser photocoagulator also has no external fiber, a wireless user interface, µSec Mode for tissue-sparing treatment, and voice control of patterns and parameters.
Oliver Hvidt, CEO and co-founder of Norlase, said in the news release the FDA clearance and CE mark approval of ECHO mark the company’s biggest 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,’ he said in a statement. “Our goal has been to develop a pattern laser that is accessible to all ophthalmologists, while maintaining our high level of innovation and precision.”
Early adopters of the laser have shared positive experiences about the laser’s functionality and treatment results.
Firas Rahhal, MD, a partner in Retina-Vitreous Associates Medical Group, said the laser proved easy to use, intuitive and efficient.
“It provides excellent power and good uptake, even when used at lower power settings,” he said in a statement. “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.”
The laser photocoagulator is the 3rd product announcement since 2019, and is part of Norlase’s series of portable and affordable laser solutions, which are quickly modernizing the way doctors treat their patients.
