FDA Approves New Excimer Laser System for LASIK
The approval allows treatments for the reduction or elimination of myopia, with or without astigmatism, ranging in severity from -1.00 to -14.00 diopters (D), in term of manifest refraction spherical equivalent (MRSE), with refractive astigmatism of less than or equal to -4.00 D cylinder by manifest refraction, in patients who are over 21 years of age.
The system is also approved for the reduction and elimination of myopia in the low, moderate, and high ranges from -0.75 to -13.00 D and moderate myopia with astigmatism ranging in severity from -1.00 to -8.00 D, with a refractive astigmatism from -0.50 to -4.00 D cylinder by manifest refraction, using Photorefractive Keratectomy (PRK).
Nidek is developing its custom ablation and wavefront technology platform with the Nidek EC-5000 Excimer Laser System. Currently this technology is available internationally and, once clinical studies are completed, will be introduced in the United States.