PZK · Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
Ophthalmic · 21 CFR 886.3600 · Class 3
Overview
| Product Code | PZK |
|---|---|
| Device Name | Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) |
| Regulation | 21 CFR 886.3600 |
| Device Class | Class 3 |
| Review Panel | Ophthalmic |
| Implant | Yes |
Identification
An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.
Classification Rationale
Class III.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P160055 | LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) | Rxsight, Inc. | Nov 22, 2017 | APPR |
Top Applicants
- Rxsight, Inc. — 1 clearance
