Keratoprosthesis, Permanent Implant
A Permanent Keratoprosthesis Implant is a surgically implanted artificial cornea device designed to replace the corneal stroma and restore vision in patients with severe corneal opacity or scarring who are not candidates for conventional corneal transplantation. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQM and is regulated under 21 CFR 886.3400, within the Ophthalmic medical specialty. It is classified as an implant.
Basic Information
- Product Code
- HQM
- Device Class
- FDA class 2
- Regulation Number
- 886.3400
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K182986 | Boston Keratoprosthesis, Type I Lucia | Jan 30, 2019 | Substantially Equivalent | Massachusetts Eye and Ear Infirmary d/b/a Boston |
| K121203 | BOSTON KERATOPROSTHESIS OR BOSTON KPRO | May 10, 2013 | Substantially Equivalent | MASSACHUSETTS EYE & EAR INFIRMARY |
| K013756 | ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) | Aug 29, 2002 | Substantially Equivalent | ARGUS BIOMEDICAL PTY LTD |
| K915062 | DOHLMAN DOANE KERATOPROTHESIS | Jan 21, 1992 | Substantially Equivalent | MACKEEN CONSULTANTS, LTD. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.