← Product Code [MLP](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MLP) · K842856

# LANDERS-FOULKS TEMP. KERATOPROSTHESIS (K842856)

_Ocular Instruments, Inc. · MLP · Dec 18, 1984 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MLP/K842856

## Device Facts

- **Applicant:** Ocular Instruments, Inc.
- **Product Code:** [MLP](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MLP.md)
- **Decision Date:** Dec 18, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.3400
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

## 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.”

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MLP/K842856](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MLP/K842856)

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