Cleared Traditional

CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS (K022373) - FDA 510(k) Clearance

Class I Ophthalmic device.

K022373 · Cantor & Nissel , Ltd. · Ophthalmic device
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Oct 2002
Decision
77d
Days
Class 1
Risk

K022373 is an FDA 510(k) clearance for the CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS. Classified as Lens, Spectacle (prescription), For Reading Discomfort (product code NJH), Class I - General Controls.

Submitted by Cantor & Nissel , Ltd. (Grand Junction, US). The FDA issued a Cleared decision on October 7, 2002 after a review of 77 days - a notably fast clearance cycle.

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: 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 Cantor & Nissel , Ltd. devices

Submission Details

510(k) Number K022373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2002
Decision Date October 07, 2002
Days to Decision 77 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
33d faster than avg
Panel avg: 110d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NJH Lens, Spectacle (prescription), For Reading Discomfort
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5844
Definition Colored Spectacle Lenses May Also Be Prescribed As A Colored Filter To Aid Individuals Who Experience Reading Discomfort Not Related To Binocular Vision Problems Or Uncorrected Refractive Error.
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.