Product code HQM
- Device name
- Keratoprosthesis, Permanent Implant
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.3400
- Review panel
- OP
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182986 | Boston Keratoprosthesis, Type I Lucia | Massachusetts Eye and Ear Infirmary D/B/A Boston | 2019-01-30 |
| K121203 | BOSTON KERATOPROSTHESIS OR BOSTON KPRO | Massachusetts Eye & Ear Infirmary | 2013-05-10 |
| K013756 | ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) | Argus Biomedical Pty, Ltd. | 2002-08-29 |
| K915062 | DOHLMAN DOANE KERATOPROTHESIS | Mackeen Consultants, Ltd. | 1992-01-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00862395000214 | Boston Keratoprosthesis Lucia Type I | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2021-10-04 |
| 00086239500214 | Boston Keratoprosthesis Lucia type I with anodized back plate | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2021-08-13 |
| 00862394000215 | Boston Keratoprosthesis Snap-on TypeI | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2015-10-30 |
| 00862394000222 | Boston Keratoprosthesis Snap-on TypeI | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2015-10-30 |
| 00862394000239 | Boston Keratoprosthesis Snap-on TypeI | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2015-10-30 |
| 00862394000246 | Boston Keratoprosthesis Snap-on TypeI | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2015-10-30 |
| 00862394000253 | Boston Keratoprosthesis Snap-on TypeI | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2015-10-30 |
| 00862394000260 | Boston Keratoprosthesis Snap-on Type I | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2015-10-30 |
| 00862394000277 | Boston Keratoprosthesis Click-on TypeI | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2015-10-30 |
| 00862394000284 | Boston Keratoprosthesis Click-on Type I | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2015-10-30 |
| 00862394000291 | Boston Keratoprosthesis Click-on Type II | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2015-10-30 |
| 00862395000207 | Boston Keratoprosthesis Click-onType II | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2015-10-30 |
| 00862394000208 | Boston Keratoprosthesis Snap-on TypeI | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. | 2015-10-29 |