HQM — Keratoprosthesis, Permanent Implant Class II

FDA Device Classification

Classification Details

Product Code
HQM
Device Class
Class II
Regulation Number
886.3400
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K182986massachusetts eye and ear infirmary d/b/a bostonBoston Keratoprosthesis, Type I LuciaJanuary 30, 2019
K121203massachusetts eye and ear infirmaryBOSTON KERATOPROSTHESIS OR BOSTON KPROMay 10, 2013
K013756argus biomedical ptyALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EAugust 29, 2002
K915062mackeen consultantsDOHLMAN DOANE KERATOPROTHESISJanuary 21, 1992