Cleared Traditional

CRISTY/COTE (K843096) - FDA 510(k) Clearance

Class I Ophthalmic device.

K843096 · Titmus Optical, Inc. · Ophthalmic device
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Nov 1984
Decision
106d
Days
Class 1
Risk

K843096 is an FDA 510(k) clearance for the CRISTY/COTE. Classified as Lens, Spectacle, Non-custom (prescription) (product code HQG), Class I - General Controls.

Submitted by Titmus Optical, Inc. (Petersburg, US). The FDA issued a Cleared decision on November 21, 1984 after a review of 106 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Titmus Optical, Inc. devices

Submission Details

510(k) Number K843096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1984
Decision Date November 21, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQG Lens, Spectacle, Non-custom (prescription)
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.