(a)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.
(b)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."
[65 FR 17147, Mar. 31, 2000]