PMA
P840047: CILCO ND:YAG LASER
FDA PMA · Laser, neodymium:Yag, ophthalmic for posterior capsulotomy and cutting pupilla · Coopervision-Cilco
Key facts
| PMA number | P840047 |
|---|---|
| Trade name | CILCO ND:YAG LASER |
| Generic name | Laser, neodymium:Yag, ophthalmic for posterior capsulotomy and cutting pupilla |
| Applicant | Coopervision-Cilco |
| Owner/operator | COOPERVISION, INC. |
| Product code | LXS |
| Approval date | Aug 2, 1985 |
| Docket number | 85M-0402 |
| Notice date | Sep 11, 1985 |
| Establishment registration | 1314956 |
| FEI number | 1314956 |
At a glance
- 1–9 Supplements
- Jan 9, 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- No Withdrawn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: