PMA
P030008: WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
FDA PMA · Excimer laser system · Alcon Laboratories, Inc.
Key facts
| PMA number | P030008 |
|---|---|
| Trade name | WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM |
| Generic name | Excimer laser system |
| Applicant | Alcon Laboratories, Inc. |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LZS |
| Approval date | Oct 10, 2003 |
| Docket number | 03M-0492 |
| Notice date | Oct 28, 2003 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- Jan 16, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: