Cleared Traditional

K934859 - CONTACT LENSES

K934859 is an FDA 510(k) clearance for CONTACT LENSES, manufactured by Arno Intl., Inc.. The device is a Class 1 Ophthalmic device with product code HPC cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K934859 · Arno Intl., Inc. · Ophthalmic device
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Dec 1993
Decision
70d
Days
Class 1
Risk

K934859 is an FDA 510(k) clearance for the CONTACT LENSES. Classified as Set, Lens, Trial, Ophthalmic (product code HPC), Class I - General Controls.

Submitted by Arno Intl., Inc. (Plantation, US). The FDA issued a Cleared decision on December 21, 1993 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1405 - 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 Arno Intl., Inc. devices

FDA 510(k) Submission Details - K934859

510(k) Number K934859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1993
Decision Date December 21, 1993
Days to Decision 70 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 110d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

HPC Device Classification - Class 1, General Controls

Product Code HPC Set, Lens, Trial, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1405
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 - HPC Set, Lens, Trial, Ophthalmic

Devices cleared under the same product code (HPC) and FDA review panel - the closest regulatory comparables to K934859.
BURTON TRIAL LENS SET
K924786 · R.H. Burton Co. · Apr 1993
TRIAL LENS SET
K920571 · R.H. Burton Co. · May 1992
WOODLYN FULL APERTURE TRIAL LENS SET
K900478 · Woodlyn, Inc. · Feb 1990
WOODLYN CLASSIC TRIAL LENS SET
K841766 · Woodlyn, Inc. · Jun 1984
LENS SET, MENTOR TRIAL
K770389 · Codman & Shurtleff, Inc. · Mar 1977