PMA supplement
P020050 S043: WaveLight EX500 Laser
FDA PMA supplement · Panel Track · Alcon Laboratories, Inc.
Key facts
| Original PMA | P020050 |
|---|---|
| Supplement number | S043 |
| Supplement type | Panel Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | WaveLight EX500 Laser |
| Generic name | Excimer laser system |
| Applicant | Alcon Laboratories, Inc. |
| Product code | LZS |
| Received date | Oct 31, 2023 |
| Decision date | Mar 5, 2025 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: