PMA
P850091: YAGMASTER ND:YAG OP LASER
FDA PMA · Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary · Bausch & Lomb, Inc.
Key facts
| PMA number | P850091 |
|---|---|
| Trade name | YAGMASTER ND:YAG OP LASER |
| Generic name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
| Applicant | Bausch & Lomb, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | LOI |
| Approval date | Apr 30, 1987 |
| Docket number | 87M-0165 |
| Notice date | Jun 10, 1987 |
| Establishment registration | 1281950 |
| FEI number | 1281950 |
At a glance
- None Supplements
- Apr 30, 1987 Latest supplement decision
- Yes Withdrawn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: