ROCHESTER, N.Y., Oct. 7 -- Bausch & Lomb announced it has received FDA clearance to market its Keracor 116 excimer laser system, despite the company's plans not to market the system in the US. The system will be restricted to those Investigational Device Exemption users previously recruited to perform the clinical studies.
Hakan Edstrom, senior vice president of Bausch & Lomb and president of its surgical and pharmaceutical divisions, stated, We are pleased with the FDA's decision to grant marketing clearance to the 116, but it is Bausch & Lomb's intent to focus its efforts on securing approval of the Technolas 217 and marketing the advanced laser system in the US. This strategy makes sense given the growing number of LASIK procedures and the fact that the 217 is the only laser specifically designed for the specialized procedure.