PMA
P830025: MEDITEC OPL3 ND:YAG LASER
FDA PMA · Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary · Medical Laser, Inc.
Key facts
| PMA number | P830025 |
|---|---|
| Trade name | MEDITEC OPL3 ND:YAG LASER |
| Generic name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
| Applicant | Medical Laser, Inc. |
| Owner/operator | Summus Medical Laser LLC |
| Product code | LOI |
| Approval date | Jan 14, 1985 |
| Docket number | 85M-0038 |
| Notice date | Feb 21, 1985 |
| Establishment registration | 3006120071 |
| FEI number | 3006120071 |
At a glance
- 1–9 Supplements
- Sep 6, 1985 Latest supplement decision
- No Withdrawn
- No 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: