OptiMedica Corp. has announced it has received FDA clearance of its Catalys Precision Laser System for creating single-plane and multi-plane arc cuts/incisions in the cornea during cataract surgery, according to a news release.
Catalys is described as a laser cataract surgery platform that combines a femtosecond laser, integrated 3D optical coherence tomography imaging and pattern scanning technology.
OptiMedica previously received FDA clearance of the system for capsulotomy and lens fragmentation. The system is now FDA market cleared and CE mark approved for all intended surgical steps.
"OptiMedica developed Catalys to deliver transformative improvements in cataract surgery, and our rapidly growing installed base of systems is a key indicator that we are achieving this objective," said Mark J. Forchette, OptiMedica president and CEO, in the release. "Catalys delivers laser cataract surgery without compromise. The system represents a stark difference from first generation laser cataract surgery technologies in that it is very easy to use and has little to no surgeon learning curve; delivers unparalleled precision and consistent performance; and provides an enhanced experience for both surgeons and patients. We are thrilled that we can now offer both U.S. and European surgeons the ability to utilize all of the procedure capabilities of Catalys."
OptiMedica Corp. is headquartered in Sunnyvale, Calif.
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