Cleared Traditional

K973528 - SUNGLASSES

K973528 is an FDA 510(k) clearance for SUNGLASSES, manufactured by Jeou Jeou Long Industrial Co., Ltd.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K973528 · Jeou Jeou Long Industrial Co., Ltd. · Ophthalmic device
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Dec 1997
Decision
82d
Days
Class 1
Risk

K973528 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 Jeou Jeou Long Industrial Co., Ltd. (Kaohsiung, TW). The FDA issued a Cleared decision on December 8, 1997 after a review of 82 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 Jeou Jeou Long Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K973528

510(k) Number K973528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1997
Decision Date December 08, 1997
Days to Decision 82 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
28d faster than avg
Panel avg: 110d · This submission: 82d
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 K973528.
NON-PRESCRIPTION SUNGLASSES
K974861 · Wenzhou Hindar Optical Co., Ltd. · Jan 1998
SUNGLASSES
K974511 · Sun World Intl., Inc. · Jan 1998
SUNGLASSES
K974441 · Hip Shing Fat Co., Ltd. · Jan 1998
MULTI
K974414 · Morning Calm Corp. · Dec 1997
NON-PRESCRIPTION SUNGLASSES
K974179 · Taipan Optical Company , Ltd. · Dec 1997
VENNETO
K974045 · Amsure Sports, Inc. · Nov 1997