PMA
P990027: TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
FDA PMA · Excimer laser system · Technolas Perfect Vision GmbH
Key facts
| PMA number | P990027 |
|---|---|
| Trade name | TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z) |
| Generic name | Excimer laser system |
| Applicant | Technolas Perfect Vision GmbH |
| Owner/operator | Technolas Perfect Vision GmbH |
| Product code | LZS |
| Approval date | Feb 23, 2000 |
| Docket number | 00M-1597 |
| Notice date | Nov 3, 2000 |
| Establishment registration | 3007606649 |
| FEI number | 3003691824 |
At a glance
- 10–99 Supplements
- Feb 6, 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- No Withdrawn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: