Bausch & Lomb
This article was originally published in The Gray Sheet
Executive Summary
Separate FDA approvals for the Technolas 116 and 217 excimer surgery laser systems are expected by the end of 1999, the company says. A May premarket approval application for the 217 for laser in situ keratomileusis was filed by the agency in mid-July; the 116 PMA was submitted in late 1997 for photorefractive keratectomy use. B&L says it will not market the 116 once approved because of technology improvements contained in the 217 system. FDA has not indicated whether its Ophthalmic Devices Panel will review the 217 PMA