Cleared Traditional

K952963 - SUNGLASSES & SPORT SUNGLASSES

K952963 is an FDA 510(k) clearance for SUNGLASSES & SPORT SUNGLASSES, manufactured by Wenzhou Winsor Optical International Co., Ltd.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K952963 · Wenzhou Winsor Optical International Co., Ltd. · Ophthalmic device
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Sep 1995
Decision
78d
Days
Class 1
Risk

K952963 is an FDA 510(k) clearance for the SUNGLASSES & SPORT SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Wenzhou Winsor Optical International Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on September 12, 1995 after a review of 78 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.

FDA 510(k) Submission Details - K952963

510(k) Number K952963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1995
Decision Date September 12, 1995
Days to Decision 78 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
32d faster than avg
Panel avg: 110d · This submission: 78d
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 645
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K952963.
SUNGLASSES
K954639 · Walmart Stores · Oct 1995
SPECTACLE SUN GLASSES (NON PRESCRIPTION)
K954173 · Monte Carlo Eyewear, Inc. · Oct 1995
SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
K952438 · Taiwan Eva Industrial Co., Inc. · Sep 1995
NIL
K953782 · Dehang Industries, Ltd. · Sep 1995
REVERT SUNGLASSES & POLAR SUNGLASSES
K953920 · Bella Occhiali, Inc. · Sep 1995
SUNGLASSES
K953947 · Wenzhou Yian Optical International, Co., Ltd. · Sep 1995
K952963 · SUNGLASSES & SPORT SUNGLASSES
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