EC-5000 Excimer Laser System

Approval order statement

Approval for the Nidek EC-5000 Excimer Laser System. This device is indicated for photorefractive keratectomy (PRK) for the reduction or elimination of mild to moderate myopia in patients with the following three characterisitics: 1) In PRK treatments for the reduction or elimination of myopia in the low, moderate, or high ranges (-0.75 Diopters (D) to -13.00D) spherical equivalent (S.E.) at the spectacle plan, uncomplicated by refractive astigmatism (i.e., <0.75D in any meridian). 2) In patients who have a stable history of pretreatment myopia, that is a change of < 0.50D in sphere or cylinder in the 12 months period preceding treatment for correction of myopia <-7.0D S.E., or a change of <1.00D in sphere or cylinder for correction of myopia >-7.0D S.E. 3) In patients who are over 21 years of age.