WaveLight EX500 Laser
Excimer laser system
Alcon Laboratories, Inc.
6201 S. Freeway
Fort Worth, TX 76134-2099
P020050
S043
10/31/2023
03/05/2025
LZS 
Ophthalmic
NCT04219891
Panel Track
Process Change - Manufacturer/Sterilizer/Packager/Supplier
No
No
No
Approval Order Statement  
Approval for the WaveLight EX500 laser system, in conjunction with INNOVEYES Sightmap, is indicated for use in INNOVEYES Laser Assisted In-Situ Keratomileusis (“wavelight plus” LASIK) treatments:• for the reduction or elimination of myopia or myopia with astigmatism, in eyes with spherical equivalent (SE) more than -1.00 and up to -9.00 diopters (D), with up to -8.00 D of spherical component (in minus cylinder format) and up to -3.00 D of astigmatic component at the spectacle plane, based on the INNOVEYES Sightmap Measured Refraction,• in patients with magnitude of the spherical equivalent (SE) difference between the Manifest Refraction (MRSE) and the Sightmap measured refraction SE being less than 0.75D,• in patients who are 18 years of age or older, and• for patients with documentation of a stable manifest refraction defined as
Approval Order
Summary of Safety and Effectiveness
Labeling
Labeling Part 2