Cleared Traditional

IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5 (K962107) - FDA 510(k) Clearance

Class I Ophthalmic device.

K962107 · Leonachi, Inc. · Ophthalmic device
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Jun 1996
Decision
20d
Days
Class 1
Risk

K962107 is an FDA 510(k) clearance for the IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Leonachi, Inc. (Miami, US). The FDA issued a Cleared decision on June 20, 1996 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5850 - 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 Leonachi, Inc. devices

Submission Details

510(k) Number K962107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1996
Decision Date June 20, 1996
Days to Decision 20 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
90d faster than avg
Panel avg: 110d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQY Sunglasses (non-prescription Including Photosensitive)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5850
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.