The FDA has granted 510(k) clearance to Quantel Medical’s integrated laser platform, Optimis Fusion.
Clermont-Ferrand, France-The FDA has granted 510(k) clearance to Quantel Medical’s integrated laser platform, Optimis Fusion.
The platform combines advanced selective laser trabeculoplasty photoregeneration therapy and traditional YAG photodisription treatments to provide ophthalmologists an armamentarium for treating both cataract and glaucoma in a combination, said the company in a prepared statement.
“We are extremely excited to bring our breakthrough laser platform to the U.S. market,” said Jean-Marc Gendre, chief executive officer of Quantel. “(It) has proven to be a very attractive laser platform since introduction earlier this year in other markets.
“Driving the acceptance of this product introduction is the ability to combine a 532-nm mono or multispot retina laser, a unique feature to Quantel’s laser line,” he added.
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