Cleared Traditional

K954075 - YEOU NAN SUNGLASSES FRAME MFG, CO., LTD.

K954075 is an FDA 510(k) clearance for YEOU NAN SUNGLASSES FRAME MFG, manufactured by Yo Nan Sunglasses Co., Ltd.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K954075 · Yo Nan Sunglasses Co., Ltd. · Ophthalmic device
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Sep 1995
Decision
13d
Days
Class 1
Risk

K954075 is an FDA 510(k) clearance for the YEOU NAN SUNGLASSES FRAME MFG, CO., LTD.. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Yo Nan Sunglasses Co., Ltd. (Tainan Hsien, TW). The FDA issued a Cleared decision on September 12, 1995 after a review of 13 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 - K954075

510(k) Number K954075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1995
Decision Date September 12, 1995
Days to Decision 13 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
97d faster than avg
Panel avg: 110d · This submission: 13d
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 K954075.
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K953629 · Lowinger Holdings, Inc. · Aug 1995
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K941084 · Blue Gem Sunglasses, Inc. · Aug 1995
MING-YA OPTICAL INDUSTRIALCO., LTD.
K951801 · Min-Ya Optical Industrial Co., Ltd. · Aug 1995
K954075 · YEOU NAN SUNGLASSES FRAME MFG, CO., LTD.
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