PMA
P970005: KREMER LASER SYSTEM
FDA PMA · Excimer laser system · Lasersight Technologies, Inc.
Key facts
| PMA number | P970005 |
|---|---|
| Trade name | KREMER LASER SYSTEM |
| Generic name | Excimer laser system |
| Applicant | Lasersight Technologies, Inc. |
| Product code | LZS |
| Approval date | Jul 30, 1998 |
| Docket number | 00M-0811 |
| FEI number | 3002741596 |
At a glance
- None Supplements
- Jul 30, 1998 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- No Withdrawn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: