PMA
P910062: VISX MODELB/MODEL C EXCIMER LASER SYSTEM
FDA PMA · Excimer laser system · Amo Manufacturing USA, LLC
Key facts
| PMA number | P910062 |
|---|---|
| Trade name | VISX MODELB/MODEL C EXCIMER LASER SYSTEM |
| Generic name | Excimer laser system |
| Applicant | Amo Manufacturing USA, LLC |
| Owner/operator | Johnson & Johnson Surgical Vision, Inc. |
| Product code | LZS |
| Approval date | Sep 29, 1995 |
| Docket number | 96M-0486 |
| Notice date | Dec 23, 1996 |
| Establishment registration | 3006695864 |
| FEI number | 3002930984 |
At a glance
- 1–9 Supplements
- Apr 12, 2019 Latest supplement decision
- No Withdrawn
- No 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: