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Optimis Fusion laser platform granted FDA 510(k) clearance

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Quantel Medical received U.S. Food and Drug Administration 510(k) clearance for its Optimis Fusion integrated laser platform, indicated to treat glaucoma, cataract and retina conditions, according to a company press release.

“We are extremely excited to bring our breakthrough laser platform to the U.S. market,” Jean-Marc Gendre, CEO of Quantel Medical, said in the press release. “The Optimis Fusion 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-spot or multi-spot retina laser, a unique feature to Quantel’s laser line.”

The system combines advanced selective laser trabeculoplasty photoregeneration therapy and traditional YAG photodisruption treatments, enabling ophthalmologists with options for treating cataract and glaucoma on a combination platform, according to the release.