510(k) K842856

LANDERS-FOULKS TEMP. KERATOPROSTHESIS by Ocular Instruments, Inc. — Product Code MLP

K842856 is an FDA 510(k) premarket notification submitted by Ocular Instruments, Inc. for the device "LANDERS-FOULKS TEMP. KERATOPROSTHESIS". The FDA issued a decision of Substantially Equivalent on December 18, 1984. The device falls under product code MLP (Keratoprosthesis, Temporary Implant, Surgical Use), a Class II device regulated under 21 CFR 886.3400. Ocular Instruments, Inc. has at least 10 other 510(k) clearances on record.