510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MLPClass II

Keratoprosthesis, Temporary Implant, Surgical Use

21 CFR 886.3400 / Ophthalmic
FDA source (opens on fda.gov)

MLP is the FDA product code for Keratoprosthesis, Temporary Implant, Surgical Use, a class II device type, regulated under 21 CFR 886.3400. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MLP
Device name
Keratoprosthesis, Temporary Implant, Surgical Use
Regulation
21 CFR 886.3400
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
5
Ingested recalls
0

Clearances, product code MLP

By decision year
5 clearances under product code MLP with a decision year between 1984 and 2026, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MLP by decision year
YearClearances
19841
19891
19901
19911
20261

Applicants with the most clearances

Product code MLP
Applicants holding the most 510(k) clearances under product code MLP
ApplicantClearances
Ocular Instruments, Inc.3
Dutch Ophthalmic USA, Inc.1
Eyekon Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code