- Device
- WaveLight EX500 Laser
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P020050
- Supplement
- S043
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2025-03-05
- Decision code
- APPR
- Date received
- 2023-10-31
- Supplement type
- Panel Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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