PMA
P040029: Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
FDA PMA · Lens, contact, orthokeratology, overnight · Euclid Vision Corporation
Key facts
| PMA number | P040029 |
|---|---|
| Trade name | Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact |
| Generic name | Lens, contact, orthokeratology, overnight |
| Applicant | Euclid Vision Corporation |
| Owner/operator | Euclid Vision Corporation |
| Product code | NUU |
| Approval date | Sep 29, 2004 |
| Docket number | 04M-0450 |
| Notice date | Oct 12, 2004 |
| Establishment registration | 3014175039 |
| FEI number | 3014175039 |
At a glance
- 10–99 Supplements
- Apr 2, 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- No Withdrawn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: