HQM · Keratoprosthesis, Permanent Implant
Ophthalmic · 21 CFR 886.3400 · Class 2
Overview
| Product Code | HQM |
|---|---|
| Device Name | Keratoprosthesis, Permanent Implant |
| Regulation | 21 CFR 886.3400 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 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 | Boston Keratoprosthesis, Type I Lucia | Massachusetts Eye and Ear Infirmary D/B/A Boston | Jan 30, 2019 | SESE |
| K121203 | BOSTON KERATOPROSTHESIS OR BOSTON KPRO | Massachusetts Eye & Ear Infirmary | May 10, 2013 | SESE |
| K013756 | ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) | Argus Biomedical Pty, Ltd. | Aug 29, 2002 | SESE |
| K915062 | 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
