PMA
P970056: BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
FDA PMA · Excimer laser system · Technolas GmbH Perfect Vision
Key facts
| PMA number | P970056 |
|---|---|
| Trade name | BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM |
| Generic name | Excimer laser system |
| Applicant | Technolas GmbH Perfect Vision |
| Owner/operator | Technolas Perfect Vision GmbH |
| Product code | LZS |
| Approval date | Sep 28, 1999 |
| Docket number | 01M-0309 |
| Notice date | Jul 23, 2001 |
| Establishment registration | 3007606649 |
| FEI number | 3003691824 |
At a glance
- None Supplements
- Sep 28, 1999 Latest supplement decision
- Yes Withdrawn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: