PMA
P850019: PHOTOTOME(TM) SYSTEM 2700
FDA PMA · Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary · Laser Media
Key facts
| PMA number | P850019 |
|---|---|
| Trade name | PHOTOTOME(TM) SYSTEM 2700 |
| Generic name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
| Applicant | Laser Media |
| Product code | LOI |
| Approval date | Aug 8, 1985 |
| Docket number | 85M-0391 |
| Notice date | Sep 18, 1985 |
| FEI number | 2021782 |
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- No Withdrawn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: