NCK — Button, Iris, Eye, Artificial Class I

FDA Device Classification

FDA product code NCK covers "Button, Iris, Eye, Artificial", a Class I medical device regulated under 21 CFR 886.3200. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
NCK
Device Class
Class I
Regulation Number
886.3200
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K001326ocular conceptsNATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTONJune 13, 2000