MLP
5 FDA 510(k) clearances · Product code
94 daysmedian time to decision
175 days90th percentile
5clearances measured
FDA profile
- Official device name
- Keratoprosthesis, Temporary Implant, Surgical Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3400
- Medical specialty
- Ophthalmic
- Flags
- Implant · Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Temporary Keratoprosthesis (QuickSet TKP™) (K261312) | Eyekon Medical, Inc. | 2026-07-24 |
| LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS (K910828) | Ocular Instruments, Inc. | 1991-08-21 |
| ECKHARDT TEMPORARY KERATOPROSTHESIS (K902491) | Dutch Ophthalmic USA, Inc. | 1990-06-26 |
| COBO TEMPORARY KERATOPROSTHESIS (K895013) | Ocular Instruments, Inc. | 1989-10-31 |
| LANDERS-FOULKS TEMP. KERATOPROSTHESIS (K842856) | Ocular Instruments, Inc. | 1984-12-18 |
Track MLP automatically
Every clearance here is in the API, with alerts when new ones post.