Cleared Traditional

CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES (K994320) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K994320 · Cantor & Silver , Ltd. · Ophthalmic device
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Oct 2000
Decision
303d
Days
Class 2
Risk

K994320 is an FDA 510(k) clearance for the CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES. Classified as Lens, Contact, For Color Vision Deficiency (product code NCZ), Class II - Special Controls.

Submitted by Cantor & Silver , Ltd. (Grand Junction, US). The FDA issued a Cleared decision on October 20, 2000 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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.

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Submission Details

510(k) Number K994320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1999
Decision Date October 20, 2000
Days to Decision 303 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
193d slower than avg
Panel avg: 110d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NCZ Lens, Contact, For Color Vision Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.