Cleared Traditional

THE INTUITIVE COLORIMETER (K012298) - FDA 510(k) Clearance

Class I Ophthalmic device.

K012298 · Cerium Optical Technologies, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Sep 2001
Decision
68d
Days
Class 1
Risk

K012298 is an FDA 510(k) clearance for the THE INTUITIVE COLORIMETER. Classified as Selector, Color, Spectacle, Lens, Tint (product code NFD), Class I - General Controls.

Submitted by Cerium Optical Technologies, Inc. (Natick, US). The FDA issued a Cleared decision on September 26, 2001 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1160 - 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 Cerium Optical Technologies, Inc. devices

Submission Details

510(k) Number K012298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2001
Decision Date September 26, 2001
Days to Decision 68 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
42d faster than avg
Panel avg: 110d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NFD Selector, Color, Spectacle, Lens, Tint
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1160
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.