PMA
P060004: MEL 80 EXCIMER LASER SYSTEM
FDA PMA · Excimer laser system · Carl Zeiss Meditec, Inc.
Key facts
| PMA number | P060004 |
|---|---|
| Trade name | MEL 80 EXCIMER LASER SYSTEM |
| Generic name | Excimer laser system |
| Applicant | Carl Zeiss Meditec, Inc. |
| Owner/operator | Carl Zeiss Meditec AG (Jena) |
| Product code | LZS |
| Approval date | Aug 11, 2006 |
| Docket number | 06M-0342 |
| Notice date | Aug 25, 2006 |
| Establishment registration | 2918630 |
| FEI number | 2918630 |
At a glance
- 10–99 Supplements
- Jul 1, 2026 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- No Withdrawn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: