Cleared Traditional

K974179 - NON-PRESCRIPTION SUNGLASSES

K974179 is an FDA 510(k) clearance for NON-PRESCRIPTION SUNGLASSES, manufactured by Taipan Optical Company , Ltd.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K974179 · Taipan Optical Company , Ltd. · Ophthalmic device
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Dec 1997
Decision
25d
Days
Class 1
Risk

K974179 is an FDA 510(k) clearance for the NON-PRESCRIPTION SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Taipan Optical Company , Ltd. (Kowloon, HK). The FDA issued a Cleared decision on December 1, 1997 after a review of 25 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 Taipan Optical Company , Ltd. devices

FDA 510(k) Submission Details - K974179

510(k) Number K974179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1997
Decision Date December 01, 1997
Days to Decision 25 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
85d faster than avg
Panel avg: 110d · This submission: 25d
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 62
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K974179.
SUNGLASSES
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SUNGLASSES
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MULTI
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VENNETO
K974045 · Amsure Sports, Inc. · Nov 1997
SUNGLASSES
K973934 · Elegance Optical Manufactory, Ltd. · Nov 1997
SUNGLASSES
K973526 · Pyramid Handbags, Inc. · Oct 1997