PMA
P040045: VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
FDA PMA · Lenses, soft contact, extended wear · Vistakon, Division of Johnson & Johnson Vision Car
Key facts
| PMA number | P040045 |
|---|---|
| Trade name | VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Vistakon, Division of Johnson & Johnson Vision Car |
| Owner/operator | Johnson & Johnson Vision Care, Inc. |
| Product code | LPM |
| Approval date | Dec 20, 2005 |
| Docket number | 05M-0504 |
| Notice date | Dec 27, 2005 |
| Establishment registration | 1057985 |
| FEI number | 1000222023 |
At a glance
- 100–999 Supplements
- Oct 8, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: