Cleared Traditional

K984219 - COLORMAX COLOR VISION ENHANCEMENT LENSES

K984219 is an FDA 510(k) clearance for COLORMAX COLOR VISION ENHANCEMENT LENSES, manufactured by Color Vision Technologies, Inc.. The device is a Class 1 Ophthalmic device with product code NAI cleared through the Traditional 510(k) pathway after a 358-day FDA review.

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

FDA 510(k) Submission Details - K984219

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
248d slower than avg
Panel avg: 110d · This submission: 358d
Pathway characteristics
Predicate-based equivalence.

NAI Device Classification - Class 1, General Controls

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.