PMA supplement
P060011 S045: RayOne Galaxy; Model RAO605G, RayOne Galaxy Toric; Model RAO615X
FDA PMA supplement · Panel Track · Rayner Intraocular Lenses, Ltd.
Key facts
| Original PMA | P060011 |
|---|---|
| Supplement number | S045 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | RayOne Galaxy; Model RAO605G, RayOne Galaxy Toric; Model RAO615X |
| Generic name | Lens, multifocal intraocular |
| Applicant | Rayner Intraocular Lenses , Ltd. |
| Product code | MFK |
| Received date | Feb 12, 2026 |
| Decision date | Sep 24, 2026 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: