Cleared Traditional

LANARD, RADIO SHADES, SUN SHADES, COOL SHADES, KOOL LOOPS, SOLAR SPEX, SHADE ZONE (K960628) - FDA 510(k) Clearance

Class I Ophthalmic device.

K960628 · Lanard Toys, Ltd. · Ophthalmic device
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Mar 1996
Decision
20d
Days
Class 1
Risk

K960628 is an FDA 510(k) clearance for the LANARD, RADIO SHADES, SUN SHADES, COOL SHADES, KOOL LOOPS, SOLAR SPEX, SHADE .... Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Lanard Toys, Ltd. (Tsimshatsui, HK). The FDA issued a Cleared decision on March 4, 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 Lanard Toys, Ltd. devices

Submission Details

510(k) Number K960628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1996
Decision Date March 04, 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.