MLP
- Product code
- MLP
- Device name
- Keratoprosthesis, Temporary Implant, Surgical Use
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.3400
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- Flag
- Implant
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 5 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261312 | 2026-07-24 | Eyekon Medical, Inc. | Temporary Keratoprosthesis (QuickSet TKP) | FDA |
Official FDA classification page: MLP
Classification and pathway per current FDA publications. Data from openFDA (CC0).