21 CFR §886.3400

1. (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.
2. (b)Classification. Class II. The special controls for this device are FDA's:
   1. (1)“Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
   2. (2)“510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
   3. (3)“Guidance on 510(k) Submissions for Keratoprostheses.”