Cleared Traditional

K961117 - VISARD SUNGLASSES

K961117 is an FDA 510(k) clearance for VISARD SUNGLASSES, manufactured by Visard Srl. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K961117 · Visard Srl · Ophthalmic device
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Apr 1996
Decision
35d
Days
Class 1
Risk

K961117 is an FDA 510(k) clearance for the VISARD SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Visard Srl (Belluno, IT). The FDA issued a Cleared decision on April 24, 1996 after a review of 35 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 Visard Srl devices

FDA 510(k) Submission Details - K961117

510(k) Number K961117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1996
Decision Date April 24, 1996
Days to Decision 35 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 110d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

HQY Device Classification - Class 1, General Controls

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.

Regulatory Peers - HQY Sunglasses (non-prescription Including Photosensitive)

All 123
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K961117.
AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE
K943145 · The Monticello Group, Inc. · Apr 1996
D & K SUNGLASSES
K960798 · D&K Stores, Inc. · Apr 1996
SUNGLASSES
K961034 · Kylie Enterprise Co. , Ltd. · Apr 1996
SUNGLASSES
K961128 · Vision-Pro Industrial, Ltd. · Apr 1996
OAKLEY, INC SUNGLASSES
K961268 · Oakley, Inc. · Apr 1996
SUNGLASSES OR MULTIPLE
K960890 · Outdoor Action Wear Specialties · Apr 1996