POE · Extended Depth Of Focus Intraocular Lens
Ophthalmic · 21 CFR 886.3600 · Class 3
Overview
| Product Code | POE |
|---|---|
| Device Name | Extended Depth Of Focus Intraocular Lens |
| 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 |
|---|---|---|---|---|
| P210005 | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | Jul 22, 2022 | APPR |
Top Applicants
- Acu Focus, Inc. — 1 clearance
