Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart D — Prosthetic Devices](/submissions/OP/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 886.3400](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3400) → MLP — Keratoprosthesis, Temporary Implant, Surgical Use

# MLP · Keratoprosthesis, Temporary Implant, Surgical Use

_Ophthalmic · 21 CFR 886.3400 · Class 2_

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

## Overview

- **Product Code:** MLP
- **Device Name:** Keratoprosthesis, Temporary Implant, Surgical Use
- **Regulation:** [21 CFR 886.3400](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3400)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes
- **Implant:** yes

## Identification

A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.

## Classification Rationale

Class II. The special controls for this device are FDA's:

## Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) “Guidance on 510(k) Submissions for Keratoprostheses.”

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K910828](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MLP/K910828.md) | LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS | Ocular Instruments, Inc. | Aug 21, 1991 | SESE |
| [K902491](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MLP/K902491.md) | ECKHARDT TEMPORARY KERATOPROSTHESIS | Dutch Ophthalmic USA, Inc. | Jun 26, 1990 | SESE |
| [K895013](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MLP/K895013.md) | COBO TEMPORARY KERATOPROSTHESIS | Ocular Instruments, Inc. | Oct 31, 1989 | SESE |
| [K842856](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MLP/K842856.md) | LANDERS-FOULKS TEMP. KERATOPROSTHESIS | Ocular Instruments, Inc. | Dec 18, 1984 | SESE |

## Top Applicants

- Ocular Instruments, Inc. — 3 clearances
- Dutch Ophthalmic USA, Inc. — 1 clearance

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

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