Cleared Traditional

K974511 - SUNGLASSES

K974511 is an FDA 510(k) clearance for SUNGLASSES, manufactured by Sun World Intl., Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K974511 · Sun World Intl., Inc. · Ophthalmic device
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Jan 1998
Decision
42d
Days
Class 1
Risk

K974511 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 Sun World Intl., Inc. (Franklin Square, US). The FDA issued a Cleared decision on January 12, 1998 after a review of 42 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 Sun World Intl., Inc. devices

FDA 510(k) Submission Details - K974511

510(k) Number K974511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1997
Decision Date January 12, 1998
Days to Decision 42 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
68d faster than avg
Panel avg: 110d · This submission: 42d
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 K974511.
NON-PRESCRIPTION SUNGLASSES
K974852 · Chia Hui Spectacles Mfg. Corp. · Jan 1998
NON-PRESCRIPTION SUNGLASSES
K974860 · Wenzhou Ming Ming Optical Co. , Ltd. · Jan 1998
NON-PRESCRIPTION SUNGLASSES
K974861 · Wenzhou Hindar Optical Co., Ltd. · Jan 1998
SUNGLASSES
K974441 · Hip Shing Fat Co., Ltd. · Jan 1998
SUNGLASSES
K973528 · Jeou Jeou Long Industrial Co., Ltd. · Dec 1997
MULTI
K974414 · Morning Calm Corp. · Dec 1997