Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: WaveLight EX500 Laser
• Generic Name: Excimer laser system
• Applicant: Alcon Laboratories, Inc.; 6201 South Freeway; Fort Worth, TX 76134-2099
• PMA Number: P020050
• Supplement Number: S043
• Date Received: 10/31/2023
• Decision Date: 03/05/2025
• Product Code: LZS
• Advisory Committee: Ophthalmic
• Clinical Trials: NCT04219891
• Supplement Type: Panel Track
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: 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: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2