ROCHESTER, N.Y., June 4 -- The US Food and Drug Administration (FDA) has accepted Bausch & Lomb's modular premarket approval application (PMA) for its Zyoptix system for customized vision correction, the company announced.
Bausch & Lomb chairman and CEO Ronald L. Zarrella said, "With our Zyoptix system, Bausch & Lomb was the first company to offer refractive surgeons and their patients truly personalized laser vision correction technology in Europe, Asia, Latin America and Canada. Our PMA submission to the FDA is a key step toward bringing this advanced technology into the important US market."
The Zyoptix system combines the Technolas 217z excimer laser with the Zyoptix diagnostic workstation, Zylink customized treatment calculation software and the Hansatome microkeratome. The Zylink software was developed solely for use with the Zyoptix system.