PMA
P220015: DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens
FDA PMA · Lens, contact, orthokeratology, overnight · Tianjin MasterVision Technology Co., Ltd.
Key facts
| PMA number | P220015 |
|---|---|
| Trade name | DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens |
| Generic name | Lens, contact, orthokeratology, overnight |
| Applicant | Tianjin MasterVision Technology Co., Ltd. |
| Product code | NUU |
| Approval date | Aug 5, 2026 |
| Docket number | 26M-8713 |
| Notice date | Aug 5, 2026 |
At a glance
- None Supplements
- Aug 5, 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- No Withdrawn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: