PMA
P980008: LASERSCAN LSX EXCIMER LASER SYSTEM
FDA PMA · Excimer laser system · Lasersight Technologies, Inc.
Key facts
| PMA number | P980008 |
|---|---|
| Trade name | LASERSCAN LSX EXCIMER LASER SYSTEM |
| Generic name | Excimer laser system |
| Applicant | Lasersight Technologies, Inc. |
| Product code | LZS |
| Approval date | Nov 12, 1999 |
| Docket number | 00M-1231 |
| FEI number | 3002741596 |
At a glance
- 1–9 Supplements
- Dec 16, 2002 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: