Product code MLP— Ophthalmic

COBO TEMPORARY KERATOPROSTHESIS

Classification name
Keratoprosthesis, Temporary Implant, Surgical Use
Device class
Class 2
Regulation
21 CFR 886.3400
Advisory panel
Ophthalmic
Total cleared
5
First cleared
Most recent

Market context for product code MLP

FDA has cleared 5 devices under product code MLP between 1984 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MLP

Recent clearances under product code MLP

Data sourced from openFDA. This site is unofficial and independent of the FDA.