FDA product code MLP: Keratoprosthesis, Temporary Implant, Surgical Use
MLP is the FDA product code for keratoprosthesis, temporary implant, surgical use. It is a Class II device, regulated under 21 CFR 886.3400 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under MLP, 1 in the last five years, from 3 different applicants. The average 510(k) review took 105 days (median 94); 94 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Keratoprosthesis, Temporary Implant, Surgical Use |
| Device class | Class II |
| Regulation | 21 CFR 886.3400 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Implant | Yes |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MLP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 94 |
Compare with all 510(k) review times · Search every MLP clearance
Top MLP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ocular Instruments, Inc. | 3 | 1991-08-21 |
| Eyekon Medical, Inc. | 1 | 2026-07-24 |
| Dutch Ophthalmic USA, Inc. | 1 | 1990-06-26 |
Most recent MLP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261312 | Eyekon Medical, Inc. | Temporary Keratoprosthesis (QuickSet TKP) | 2026-07-24 | 94 |
| K910828 | Ocular Instruments, Inc. | LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS | 1991-08-21 | 175 |
| K902491 | Dutch Ophthalmic USA, Inc. | ECKHARDT TEMPORARY KERATOPROSTHESIS | 1990-06-26 | 21 |
| K895013 | Ocular Instruments, Inc. | COBO TEMPORARY KERATOPROSTHESIS | 1989-10-31 | 84 |
| K842856 | Ocular Instruments, Inc. | LANDERS-FOULKS TEMP. KERATOPROSTHESIS | 1984-12-18 | 151 |
Recalls for MLP devices
openFDA lists no recalls for product code MLP.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8616 — Microphone for use with cochlear implant device, replacement
- L8617 — Transmitting coil for use with cochlear implant device, replacement
- L8615 — Headset/headpiece for use with cochlear implant device, replacement
- L8629 — Transmitting coil and cable, integrated, for use with cochlear implant device, replacement
- L8618 — Transmitter cable for use with cochlear implant device or auditory osseointegrated device, replacement
Frequently asked questions
What is FDA product code MLP?
MLP is the FDA product code for keratoprosthesis, temporary implant, surgical use. It is a Class II device, regulated under 21 CFR 886.3400 and reviewed by the Ophthalmic panel.
What device class is MLP?
Class II, regulation 21 CFR 886.3400. Typical premarket route: 510(k).
How long does a 510(k) take for product code MLP?
Across 5 cleared submissions the average was 105 days from receipt to decision (median 94).
Which companies have the most MLP clearances?
Ocular Instruments, Inc. (3); Eyekon Medical, Inc. (1); Dutch Ophthalmic USA, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MLP
- Run a recall and safety report across every MLP manufacturer
- Watch product code MLP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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