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