PMA
P240038: FINEVISION HP Trifocal IOLs
FDA PMA · Intraocular lens · Beaver Visitec International, Inc.
Key facts
| PMA number | P240038 |
|---|---|
| Trade name | FINEVISION HP Trifocal IOLs |
| Generic name | Intraocular lens |
| Applicant | Beaver Visitec International, Inc. |
| Owner/operator | Beaver-Visitec International, Inc. |
| Product code | HQL |
| Approval date | Sep 10, 2025 |
| Docket number | FDA-3951 |
| Establishment registration | 1211998 |
| FEI number | 1211998 |
At a glance
- 1–9 Supplements
- Sep 25, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: