Cleared Traditional

CHROMAGEN V3.0 READING AID SOFT CONTACT LENS (K012132) - FDA 510(k) Clearance

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

K012132 · Cantor & Nissel , Ltd. · Ophthalmic device
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May 2002
Decision
304d
Days
Class 2
Risk

K012132 is an FDA 510(k) clearance for the CHROMAGEN V3.0 READING AID SOFT CONTACT LENS. Classified as Lens, Contact, For Reading Discomfort (product code NIC), Class II - Special Controls.

Submitted by Cantor & Nissel , Ltd. (Grand Junction, US). The FDA issued a Cleared decision on May 9, 2002 after a review of 304 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.

View all Cantor & Nissel , Ltd. devices

Submission Details

510(k) Number K012132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2001
Decision Date May 09, 2002
Days to Decision 304 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
194d slower than avg
Panel avg: 110d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NIC Lens, Contact, For Reading Discomfort
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
Definition This Lens Is Indicated For Daily Wear For The Correction Of Refractive Ametropia In Persons With Non-diseased Eyes. This Lens 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 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.