MLP · Keratoprosthesis, Temporary Implant, Surgical Use
Ophthalmic · 21 CFR 886.3400 · Class 2
Overview
| Product Code | MLP |
|---|---|
| Device Name | Keratoprosthesis, Temporary Implant, Surgical Use |
| Regulation | 21 CFR 886.3400 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 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.”
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K910828 | LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS | Ocular Instruments, Inc. | Aug 21, 1991 | SESE |
| K902491 | ECKHARDT TEMPORARY KERATOPROSTHESIS | Dutch Ophthalmic USA, Inc. | Jun 26, 1990 | SESE |
| K895013 | COBO TEMPORARY KERATOPROSTHESIS | Ocular Instruments, Inc. | Oct 31, 1989 | SESE |
| K842856 | LANDERS-FOULKS TEMP. KERATOPROSTHESIS | Ocular Instruments, Inc. | Dec 18, 1984 | SESE |
Top Applicants
- Ocular Instruments, Inc. — 3 clearances
- Dutch Ophthalmic USA, Inc. — 1 clearance
