PMA
P830080: PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER
FDA PMA · Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary · Synemed, Inc.
Key facts
| PMA number | P830080 |
|---|---|
| Trade name | PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER |
| Generic name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
| Applicant | Synemed, Inc. |
| Product code | LOI |
| Approval date | Feb 17, 1987 |
| Docket number | 87M-0077 |
| Notice date | Apr 6, 1987 |
At a glance
- None Supplements
- Feb 17, 1987 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- No Withdrawn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: