IRVINE, Calif., Jan. 19 -- IntraLase Corp. reports that the US Food and Drug Administration has granted 510(k) clearance for the company's Femtosecond Laser Keratome System. The FDA clearance will allow IntraLase to market, sell and distribute its laser system in the US as an alternative to mechanical microkeratomes. The company said the laser technology is aimed at replacing microkeratomes, which use blades to create a corneal flap prior to laser vision correction procedures.
Ron Kurtz, IntraLase's vice president and medical director, noted, Clinical results in our European patients have been excellent, displaying extremely high reproducibility of flap parameters and post-operative flap stability.