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) → HQM — Keratoprosthesis, Permanent Implant

# HQM · Keratoprosthesis, Permanent Implant

_Ophthalmic · 21 CFR 886.3400 · Class 2_

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

## Overview

- **Product Code:** HQM
- **Device Name:** Keratoprosthesis, Permanent Implant
- **Regulation:** [21 CFR 886.3400](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3400)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **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 |
| --- | --- | --- | --- | --- |
| [K182986](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQM/K182986.md) | Boston Keratoprosthesis, Type I Lucia | Massachusetts Eye and Ear Infirmary D/B/A Boston | Jan 30, 2019 | SESE |
| [K121203](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQM/K121203.md) | BOSTON KERATOPROSTHESIS OR BOSTON KPRO | Massachusetts Eye & Ear Infirmary | May 10, 2013 | SESE |
| [K013756](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQM/K013756.md) | ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) | Argus Biomedical Pty, Ltd. | Aug 29, 2002 | SESE |
| [K915062](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQM/K915062.md) | DOHLMAN DOANE KERATOPROTHESIS | Mackeen Consultants, Ltd. | Jan 21, 1992 | SESE |

## Top Applicants

- Argus Biomedical Pty, Ltd. — 1 clearance
- Mackeen Consultants, Ltd. — 1 clearance
- Massachusetts Eye & Ear Infirmary — 1 clearance
- Massachusetts Eye and Ear Infirmary D/B/A Boston — 1 clearance

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

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