FDA Product Code
FDA Product Code MLP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.3400
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261312 | Temporary Keratoprosthesis (QuickSet TKP) | Eyekon Medical, Inc. | 2026-07-24 | Traditional | PDF ↗ |
| K910828 | LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS | Ocular Instruments, Inc. | 1991-08-21 | Traditional | PDF ↗ |
| K902491 | ECKHARDT TEMPORARY KERATOPROSTHESIS | Dutch Ophthalmic USA, Inc. | 1990-06-26 | Traditional | PDF ↗ |
| K895013 | COBO TEMPORARY KERATOPROSTHESIS | Ocular Instruments, Inc. | 1989-10-31 | Traditional | PDF ↗ |
| K842856 | LANDERS-FOULKS TEMP. KERATOPROSTHESIS | Ocular Instruments, Inc. | 1984-12-18 | Traditional | PDF ↗ |
Product code MLP · Class II · Ophthalmic. Data: openFDA.