PMA
P060011: C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
FDA PMA · Intraocular lens · Rayner Intraocular Lenses, Ltd.
Key facts
| PMA number | P060011 |
|---|---|
| Trade name | C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) |
| Generic name | Intraocular lens |
| Applicant | Rayner Intraocular Lenses , Ltd. |
| Owner/operator | Rayner Intraocular Lenses Limited |
| Product code | HQL |
| Approval date | May 3, 2007 |
| Docket number | 07M-0189 |
| Notice date | May 11, 2007 |
| Establishment registration | 3012304651 |
| FEI number | 3012304651 |
At a glance
- 10–99 Supplements
- Sep 24, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: