Section 886.3400 - Keratoprosthesis(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