PMA supplement
P160055 S008: Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
FDA PMA supplement · Real-Time Process · Rxsight, Inc.
Key facts
| Original PMA | P160055 |
|---|---|
| Supplement number | S008 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
| Generic name | Light adjustable lens (LAL) and light delivery device (LDD) |
| Applicant | Rxsight, Inc. |
| Product code | PZK |
| Received date | Sep 13, 2019 |
| Decision date | Nov 22, 2019 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: