FDA clears OptiMedica ophthalmic laser system

Ophthalmic company OptiMedica (Santa Clara, CA) has received FDA clearance of its Catalys Precision Laser System, a laser cataract surgery system that combines a femtosecond laser, integrated optical coherence tomography (OCT) imaging, and the company's pattern scanning technology. The system enables cataract surgeons to perform image-guided pre-operative laser lens conditioning, and is FDA-cleared for capsulotomy and lens fragmentation.

Clinical study results published in the Journal of Cataract & Refractive Surgery have demonstrated that the Catalys system produces capsulotomies that are within 30 µm of intended size and 80 µm of intended center. Also, laser lens fragmentation with the system reduces cumulative dissipated energy (CDE) during ultrasound phacoemulsification by approximately 40 percent, according to the study.

The Catalys system was CE mark-approved in August 2011 and has since been shipped to ophthalmic centers outside the U.S.


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