PMA
P970053: EC-5000 EXCIMER LASER SYSTEM
FDA PMA · Excimer laser system · Nidek Co., Ltd.
Key facts
| PMA number | P970053 |
|---|---|
| Trade name | EC-5000 EXCIMER LASER SYSTEM |
| Generic name | Excimer laser system |
| Applicant | Nidek Co., Ltd. |
| Owner/operator | NIDEK CO., LTD. |
| Product code | LZS |
| Approval date | Dec 17, 1998 |
| Docket number | 00M-1640 |
| Notice date | Dec 8, 2000 |
| Establishment registration | 2936921 |
| FEI number | 2936921 |
At a glance
- 10–99 Supplements
- Jan 12, 2018 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- No Withdrawn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: