PMA
P860022: BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
FDA PMA · Lens, contact (rigid gas permeable), extended wear · Bausch & Lomb
Key facts
| PMA number | P860022 |
|---|---|
| Trade name | BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
| Generic name | Lens, contact (rigid gas permeable), extended wear |
| Applicant | Bausch & Lomb |
| Owner/operator | POLYMER TECHNOLOGY SYSTEMS, INC. |
| Product code | MWL |
| Approval date | Nov 30, 1987 |
| Docket number | 87M-0395 |
| Notice date | Jan 19, 1988 |
| Establishment registration | 3015525148 |
| FEI number | 3002698769 |
At a glance
- 10–99 Supplements
- Dec 16, 2025 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- No Withdrawn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: