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Femtosecond laser cataract surgery system gets 510(k) clearance

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SANTA CLARA, Calif. — The Catalys Precision Laser System from OptiMedica Corp. has been granted 510(k) clearance by the U.S. Food and Drug Administration, according to a press release.

The system, which combines a femtosecond laser with integrated optical coherence tomography and OptiMedica's pattern-scanning technology, was cleared for capsulotomy and lens fragmentation procedures, the release said.

"The FDA approval of Catalys is an exciting development in the emerging field of laser cataract surgery and a key milestone in the history of OptiMedica," Mark J. Forchette, OptiMedica president and chief executive officer, said in the release.

Clinical studies of the system demonstrated it offers remarkable accuracy and can produce capsulotomies within 30 microns of the intended size and 80 microns of the intended center with almost perfect circularity, according to the release.

"My colleagues and I have been fortunate to have access to the Catalys technology for years, and we firmly believe it will revolutionize cataract surgery," William J. Culbertson, MD, professor of ophthalmology, Lou Higgins Distinguished Chair in Ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, said in the release.