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Zyoptix to get ‘substantive review’ by FDA

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ROCHESTER, N.Y. — The Food and Drug Administration will begin a “substantive review” of Bausch & Lomb’s Zyoptix system for personalized vision correction. The regulatory agency has completed its initial review of the company's premarket approval application and has deemed the PMA suitable for filing. Zyoptix is designed to correct myopic and astigmatic refractive errors.

Zyoptix is currently available throughout Europe, Asia, Latin America and Canada. Zyoptix combines B&L’s Technolas 217 excimer laser with a diagnostic capability and customized treatment calculation program.