Cleared Traditional

K952438 - SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)

K952438 is an FDA 510(k) clearance for SUNGLASSES (NON-PRESCRIPTION INCLUDING ..., manufactured by Taiwan Eva Industrial Co., Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K952438 · Taiwan Eva Industrial Co., Inc. · Ophthalmic device
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Sep 1995
Decision
110d
Days
Class 1
Risk

K952438 is an FDA 510(k) clearance for the SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE). Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Taiwan Eva Industrial Co., Inc. (Kaohsiung, TW). The FDA issued a Cleared decision on September 12, 1995 after a review of 110 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.

FDA 510(k) Submission Details - K952438

510(k) Number K952438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1995
Decision Date September 12, 1995
Days to Decision 110 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
At panel average
Panel avg: 110d · This submission: 110d
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 K952438.
BLINDE OPTICS
K954636 · Blinde Eyewear, Inc. · Oct 1995
SUNGLASSES
K954639 · Walmart Stores · Oct 1995
SPECTACLE SUN GLASSES (NON PRESCRIPTION)
K954173 · Monte Carlo Eyewear, Inc. · Oct 1995
SUNGLASSES & SPORT SUNGLASSES
K952963 · Wenzhou Winsor Optical International Co., Ltd. · Sep 1995
NIL
K953782 · Dehang Industries, Ltd. · Sep 1995
REVERT SUNGLASSES & POLAR SUNGLASSES
K953920 · Bella Occhiali, Inc. · Sep 1995
K952438 · SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
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