Cleared Traditional

COLORMAX COLOR VISION ENHANCEMENT LENSES (K984219) - FDA 510(k) Clearance

Class I Ophthalmic device.

K984219 · Color Vision Technologies, Inc. · Ophthalmic device
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Nov 1999
Decision
358d
Days
Class 1
Risk

K984219 is an FDA 510(k) clearance for the COLORMAX COLOR VISION ENHANCEMENT LENSES. Classified as Lens, Prescription, Color Deficiency (product code NAI), Class I - General Controls.

Submitted by Color Vision Technologies, Inc. (Rowland Heights, US). The FDA issued a Cleared decision on November 18, 1999 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5844 - 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. Elevated predicate reliance profile. 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 Color Vision Technologies, Inc. devices

Submission Details

510(k) Number K984219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1998
Decision Date November 18, 1999
Days to Decision 358 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
248d slower than avg
Panel avg: 110d · This submission: 358d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAI Lens, Prescription, Color Deficiency
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5844
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.