The US Food and Drug Administration (FDA) has granted 510(k) approval to OptiMedica's new Catalys Precision Laser system, designed for creating single-plane and multi-plane arc cuts and incisions in the cornea during 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 features a Liquid Optics Interface that optimises 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 minimises the time the patient is under the dock.
University Eye Clinic, Bochum, Germany, chairman and head, professor Burkhard Dick said; "I have found that Catalys' unequaled performance and ease of use have made it the ideal platform for treating my cataract patients, including even the most challenging cases."
OptiMedica president and CEO Mark Forchette said 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," Forchette said.
"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."