Cleared Traditional

K874845 - MALIS SURGICAL LOUPES (FDA 510(k) Clearance)

Class I Ophthalmic device.

K874845 · Valley Forge Scientific Corp. · Ophthalmic device
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Dec 1987
Decision
29d
Days
Class 1
Risk

K874845 is an FDA 510(k) clearance for the MALIS SURGICAL LOUPES. Classified as Loupe, Binocular, Low Power (product code HJH), Class I - General Controls.

Submitted by Valley Forge Scientific Corp. (Valley Forge, US). The FDA issued a Cleared decision on December 23, 1987 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5120 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Valley Forge Scientific Corp. devices

Submission Details

510(k) Number K874845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1987
Decision Date December 23, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HJH Loupe, Binocular, Low Power
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5120
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.