Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart D — Prosthetic Devices](/submissions/OP/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 886.3600](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3600) → POE — Extended Depth Of Focus Intraocular Lens

# POE · Extended Depth Of Focus Intraocular Lens

_Ophthalmic · 21 CFR 886.3600 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/POE

## Overview

- **Product Code:** POE
- **Device Name:** Extended Depth Of Focus Intraocular Lens
- **Regulation:** [21 CFR 886.3600](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3600)
- **Device Class:** 3
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **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](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/POE/P210005.md) | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | Jul 22, 2022 | APPR |

## Top Applicants

- Acu Focus, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/POE](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/POE)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com