Cleared Traditional

K843096 - CRISTY/COTE

K843096 is an FDA 510(k) clearance for CRISTY/COTE, manufactured by Titmus Optical, Inc.. The device is a Class 1 Ophthalmic device with product code HQG cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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

FDA 510(k) Submission Details - K843096

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.

HQG Device Classification - Class 1, General Controls

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.

Regulatory Peers - HQG Lens, Spectacle, Non-custom (prescription)

All 8
Devices cleared under the same product code (HQG) and FDA review panel - the closest regulatory comparables to K843096.
FORMALENS 2000
K863367 · Vision-Sciences, Inc. · Sep 1986
SPECTACLES LENS
K860955 · Roseburg SA · Mar 1986
CORNING CPF 550 LENS
K821398 · Corning Medical & Scientific · Jun 1982
PHOTOLITE AOLITE TINTOMATIC LENS
K812051 · American Optical Corp. · Sep 1981
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
K802651 · Chiron Vision Corp. · Dec 1980
ULTRAVUE BLENDED BIFOCAL LENS
K791721 · American Optical Corp. · Oct 1979