Cleared Traditional

K844365 - COLOR VISION TESTERS

K844365 is an FDA 510(k) clearance for COLOR VISION TESTERS, manufactured by Luneau Laboratories. The device is a Class 1 Ophthalmic device with product code HIT cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K844365 · Luneau Laboratories · Ophthalmic device
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Jan 1985
Decision
50d
Days
Class 1
Risk

K844365 is an FDA 510(k) clearance for the COLOR VISION TESTERS. Classified as Tester, Color Vision (product code HIT), Class I - General Controls.

Submitted by Luneau Laboratories (Walker, US). The FDA issued a Cleared decision on January 2, 1985 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1170 - 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.

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FDA 510(k) Submission Details - K844365

510(k) Number K844365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date January 02, 1985
Days to Decision 50 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 110d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

HIT Device Classification - Class 1, General Controls

Product Code HIT Tester, Color Vision
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1170
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.