Cleared Traditional

K964082 - SUNGLASSES

K964082 is an FDA 510(k) clearance for SUNGLASSES, manufactured by Neo Vu, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K964082 · Neo Vu, Inc. · Ophthalmic device
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Nov 1996
Decision
45d
Days
Class 1
Risk

K964082 is an FDA 510(k) clearance for the SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Neo Vu, Inc. (New York, US). The FDA issued a Cleared decision on November 25, 1996 after a review of 45 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 Neo Vu, Inc. devices

FDA 510(k) Submission Details - K964082

510(k) Number K964082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1996
Decision Date November 25, 1996
Days to Decision 45 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
65d faster than avg
Panel avg: 110d · This submission: 45d
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 K964082.
PLASTIC SUNGLASSES
K964316 · Medical Reports Exchange, Inc. · Dec 1996
SUNGLASSES OR MULTIPLE
K964429 · Trade Resources , Ltd. · Dec 1996
SPENSER SUNGLASSES AND SPORT SUNGLASSES
K964058 · Spencer Products Co. · Nov 1996
SUNGLASSES(NON-PRESCRIPTION)
K964413 · Ever Prime Enterprises , Ltd. · Nov 1996
VARIOUS SUNGLASSES (NON-PRESCRIPTION)
K963890 · Italian Eyewear, Inc. · Nov 1996
DR. BERT'S SUNCARE PRODUCTS PEEPER KEEPERS
K963955 · Bert & Joe'S, Inc. · Nov 1996