HQM — Keratoprosthesis, Permanent Implant Class II
FDA product code HQM covers "Keratoprosthesis, Permanent Implant", a Class II medical device regulated under 21 CFR 886.3400. Submissions are reviewed by the Ophthalmic panel. Devices under this code are implants. At least 4 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K182986 | massachusetts eye and ear infirmary d/b/a boston | Boston Keratoprosthesis, Type I Lucia | January 30, 2019 |
| K121203 | massachusetts eye and ear infirmary | BOSTON KERATOPROSTHESIS OR BOSTON KPRO | May 10, 2013 |
| K013756 | argus biomedical pty | ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC E | August 29, 2002 |
| K915062 | mackeen consultants | DOHLMAN DOANE KERATOPROTHESIS | January 21, 1992 |