OptiMedica has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Catalys Precision Laser system, designed for creating single-plane and multi-plane arc cuts/incisions in the cornea during performing cataract surgery.
The CE-marked Catalys system combines a femtosecond laser, integrated 3D optical coherence tomography imaging as well as the company's pattern scanning technology to deliver transformative improvements in cataract surgery.
Catalys system features a Liquid Optics Interface that optimizes the optical path to the patient's eye and a proprietary Integral Guidance mapping system, designed to ensure that the femtosecond laser pulses are delivered safely and precisely to the intended location.
In addition, Catalys includes an easy-to-use graphical user interface which simplifies the planning process and minimizes the time, while the patient is under the dock.
OptiMedica president and chief executive officer Mark Forchette said Catalys system 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," Forchette added.
"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."