Excimer Laser System
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Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- WaveLight EX500 Laser
- PMA Number
- P020050
- Supplement Number
- S043
- Device Class
- FDA Class 3
- Product Code
- LZS
- Generic Name
- Excimer laser system
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 5, 2025
- Date Received
- October 31, 2023
- Supplement Type
- Panel Track
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee 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 </= 0.5 D preoperative spherical equivalent shift over one year prior to surgery.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZS | Excimer Laser System | FDA class 3 | Unknown |