Cleared Traditional

K842856 - LANDERS-FOULKS TEMP. KERATOPROSTHESIS

K842856 is an FDA 510(k) clearance for LANDERS-FOULKS TEMP. KERATOPROSTHESIS, manufactured by Ocular Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code MLP cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K842856 · Ocular Instruments, Inc. · Ophthalmic device
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Dec 1984
Decision
151d
Days
Class 2
Risk

K842856 is an FDA 510(k) clearance for the LANDERS-FOULKS TEMP. KERATOPROSTHESIS. Classified as Keratoprosthesis, Temporary Implant, Surgical Use (product code MLP), Class II - Special Controls.

Submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on December 18, 1984 after a review of 151 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3400 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ocular Instruments, Inc. devices

FDA 510(k) Submission Details - K842856

510(k) Number K842856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date December 18, 1984
Days to Decision 151 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 110d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLP Device Classification - Class 2, Special Controls

Product Code MLP Keratoprosthesis, Temporary Implant, Surgical Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.