PMA
P160055: LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)
FDA PMA · Light adjustable lens (LAL) and light delivery device (LDD) · Rxsight, Inc.
Key facts
| PMA number | P160055 |
|---|---|
| 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. |
| Owner/operator | RxSight Inc. |
| Product code | PZK |
| Approval date | Nov 22, 2017 |
| Docket number | 17M-6614 |
| Notice date | Dec 5, 2017 |
| Establishment registration | 3012712027 |
| FEI number | 3012712027 |
At a glance
- 10–99 Supplements
- Sep 3, 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- No Withdrawn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: