Cleared Traditional

DUALENZ LOW VISION EYEWEAR (K864594) - FDA 510(k) Clearance

Class I Ophthalmic device.

K864594 · Global Eye Care, Inc. · Ophthalmic device
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Jan 1987
Decision
60d
Days
Class 1
Risk

K864594 is an FDA 510(k) clearance for the DUALENZ LOW VISION EYEWEAR. Classified as Telescope, Spectacle, Low-vision (product code HKK), Class I - General Controls.

Submitted by Global Eye Care, Inc. (Rochester, US). The FDA issued a Cleared decision on January 20, 1987 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5870 - 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 Global Eye Care, Inc. devices

Submission Details

510(k) Number K864594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1986
Decision Date January 20, 1987
Days to Decision 60 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 110d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKK Telescope, Spectacle, Low-vision
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5870
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.