ECKHARDT TEMPORARY KERATOPROSTHESIS
Device Facts
| Record ID | K902491 |
|---|---|
| Device Name | ECKHARDT TEMPORARY KERATOPROSTHESIS |
| Applicant | Dutch Ophthalmic USA, Inc. |
| Product Code | MLP · Ophthalmic |
| Decision Date | Jun 26, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.3400 |
| Device Class | Class 2 |
Regulatory Classification
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.”
