OptiMedica Catalys Precision Laser System for creating corneal incisions receives FDA 510(k) clearance

Published on September 5, 2012 at 5:51 AM · No Comments

Global ophthalmic company OptiMedica Corp. has announced U.S. Food and Drug Administration 510(k) market clearance of its Catalys Precision Laser System for creating single-plane and multi-plane arc cuts/incisions in the cornea during cataract surgery. The system, which was CE mark approved for these incisions in March of 2012, is now both CE mark approved and FDA market cleared for this indication as well as capsulotomy and/or lens fragmentation.

“Catalys' corneal incisions application is yet another example of the innovation I have come to expect from OptiMedica”

"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 chief executive officer. "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."

Prof. Burkhard Dick, chairman and head of the University Eye Clinic Bochum, Germany, was first in Europe to use Catalys to perform corneal incisions. To date, he has incorporated this step into more than 150 cataract surgery cases.

"Catalys' corneal incisions application is yet another example of the innovation I have come to expect from OptiMedica," said Prof. Dick. "The improvement the system makes in the quality of these incisions is, once again, considerable. 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."

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