PMA
P150040: VISUMAX FEMTOSECOND LASER
FDA PMA · Femtosecond laser system for refractive correction · Carl Zeiss Meditec, Inc.
Key facts
| PMA number | P150040 |
|---|---|
| Trade name | VISUMAX FEMTOSECOND LASER |
| Generic name | Femtosecond laser system for refractive correction |
| Applicant | Carl Zeiss Meditec, Inc. |
| Owner/operator | Carl Zeiss Meditec AG (Jena) |
| Product code | OTL |
| Approval date | Sep 13, 2016 |
| Docket number | 16M-2735 |
| Notice date | Sep 16, 2016 |
| Establishment registration | 2918630 |
| FEI number | 2918630 |
At a glance
- 10–99 Supplements
- May 26, 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- No Withdrawn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: