HQM · Class II · 21 CFR 886.3400

FDA Product Code HQM: Keratoprosthesis, Permanent Implant

Leading manufacturers include Argus Biomedical Pty, Ltd., Massachusetts Eye & Ear Infirmary and Massachusetts Eye and Ear Infirmary D/B/A Boston.

4
Total
4
Cleared
210d
Avg days
1992
Since

FDA 510(k) Cleared Keratoprosthesis, Permanent Implant Devices (Product Code HQM)

4 devices
1–4 of 4
Cleared Jan 30, 2019
Boston Keratoprosthesis, Type I Lucia
K182986
Massachusetts Eye and Ear Infirmary D/B/A Boston
Ophthalmic · 93d
Cleared May 10, 2013
BOSTON KERATOPROSTHESIS OR BOSTON KPRO
K121203
Massachusetts Eye & Ear Infirmary
Ophthalmic · 385d
Cleared Aug 29, 2002
ALPHACOR
K013756
Argus Biomedical Pty, Ltd.
Ophthalmic · 289d
Cleared Jan 21, 1992
DOHLMAN DOANE KERATOPROTHESIS
K915062
Mackeen Consultants, Ltd.
Ophthalmic · 74d

About Product Code HQM - Regulatory Context