21 CFR 886.3400 — Keratoprosthesis, Permanent Implant
Ophthalmic (OP) · Part 886 Subpart D—Prosthetic Devices · § 886.3400
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:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HQM | Keratoprosthesis, Permanent Implant | 2 | 4 | Implant |
| MLP | Keratoprosthesis, Temporary Implant, Surgical Use | 2 | 4 | 3rd Party, Implant |
Special Controls
HQM — Keratoprosthesis, Permanent Implant
*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.”
eCFR
MLP — Keratoprosthesis, Temporary Implant, Surgical Use
*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.”
eCFR
