§ 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]