PMA
P180035: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
FDA PMA · Daily wear soft contact lens to reduce the progression of myopia · CooperVision, Inc.
Key facts
| PMA number | P180035 |
|---|---|
| Trade name | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear |
| Generic name | Daily wear soft contact lens to reduce the progression of myopia |
| Applicant | CooperVision, Inc. |
| Owner/operator | COOPERVISION, INC. |
| Product code | QIT |
| Approval date | Nov 15, 2019 |
| Docket number | 19M-5438 |
| Notice date | Nov 19, 2019 |
| Establishment registration | 3005724763 |
| FEI number | 3005724763 |
At a glance
- 10–99 Supplements
- Feb 17, 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- No Withdrawn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: