Cleared Traditional

K971385 - SUNGLASSES

K971385 is an FDA 510(k) clearance for SUNGLASSES, manufactured by Kosway Industries Co., Ltd.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K971385 · Kosway Industries Co., Ltd. · Ophthalmic device
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Jul 1997
Decision
91d
Days
Class 1
Risk

K971385 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 Kosway Industries Co., Ltd. (Tuen Mun, N.T., HK). The FDA issued a Cleared decision on July 14, 1997 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Kosway Industries Co., Ltd. devices

FDA 510(k) Submission Details - K971385

510(k) Number K971385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1997
Decision Date July 14, 1997
Days to Decision 91 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
19d faster than avg
Panel avg: 110d · This submission: 91d
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 K971385.
NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES
K972590 · Lbi U.S.A. · Jul 1997
D'ARC EYE CARE SUNGLASSES
K972490 · M & R Dist. · Jul 1997
MOMO DESIGN OR MOMO
K972416 · Momo U.S.A., Inc. · Jul 1997
FOVS, BRILLARTE, ETC...
K972362 · Sunglass City, Inc. · Jul 1997
(BRAND NAME)
K971384 · Long IN Time Ent. Co., Ltd. · Jul 1997
SUNGLASSES
K971462 · D.G. Prove Co. · Jul 1997