MLP · Class II · 21 CFR 886.3400

FDA Product Code MLP: Keratoprosthesis, Temporary Implant, Surgical Use

Leading manufacturers include Ocular Instruments, Inc..

5
Total
5
Cleared
105d
Avg days
1984
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 94d avg (recent)

FDA 510(k) Cleared Keratoprosthesis, Temporary Implant, Surgical Use Devices (Product Code MLP)

5 devices
1–5 of 5
Cleared Aug 21, 1991
LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS
K910828
Ocular Instruments, Inc.
Ophthalmic · 175d
Cleared Oct 31, 1989
COBO TEMPORARY KERATOPROSTHESIS
K895013
Ocular Instruments, Inc.
Ophthalmic · 84d
Cleared Dec 18, 1984
LANDERS-FOULKS TEMP. KERATOPROSTHESIS
K842856
Ocular Instruments, Inc.
Ophthalmic · 151d

About Product Code MLP - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code MLP since 1984, with 5 receiving FDA clearance (average review time: 105 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MLP Product Code

FDA review times for MLP submissions have been consistent, averaging 94 days recently vs 108 days historically.

MLP devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →