FDA Product Code
FDA Product Code HQM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.3400
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K182986 | Boston Keratoprosthesis, Type I Lucia | Massachusetts Eye and Ear Infirmary D/B/A Boston | 2019-01-30 | Special | PDF ↗ |
| K121203 | BOSTON KERATOPROSTHESIS OR BOSTON KPRO | Massachusetts Eye & Ear Infirmary | 2013-05-10 | Traditional | PDF ↗ |
| K013756 | ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) | Argus Biomedical Pty, Ltd. | 2002-08-29 | Traditional | PDF ↗ |
| K915062 | DOHLMAN DOANE KERATOPROTHESIS | Mackeen Consultants, Ltd. | 1992-01-21 | Traditional | PDF ↗ |
Product code HQM · Class II · Ophthalmic. Data: openFDA.