Cleared Traditional

K951801 - MING-YA OPTICAL INDUSTRIALCO., LTD.

K951801 is an FDA 510(k) clearance for MING-YA OPTICAL INDUSTRIALCO., manufactured by Min-Ya Optical Industrial Co., Ltd.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K951801 · Min-Ya Optical Industrial Co., Ltd. · Ophthalmic device
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Aug 1995
Decision
118d
Days
Class 1
Risk

K951801 is an FDA 510(k) clearance for the MING-YA OPTICAL INDUSTRIALCO., LTD.. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Min-Ya Optical Industrial Co., Ltd. (Chiayi, TW). The FDA issued a Cleared decision on August 14, 1995 after a review of 118 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 - K951801

510(k) Number K951801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1995
Decision Date August 14, 1995
Days to Decision 118 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
8d slower than avg
Panel avg: 110d · This submission: 118d
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 K951801.
YEOU NAN SUNGLASSES FRAME MFG, CO., LTD.
K954075 · Yo Nan Sunglasses Co., Ltd. · Sep 1995
SPECTACLE SUNGLASSES(NON-PRESCRIPTION)
K953629 · Lowinger Holdings, Inc. · Aug 1995
SUNGLASSES
K941084 · Blue Gem Sunglasses, Inc. · Aug 1995
HENNERT SA
K952734 · Hennert S.A. · Aug 1995
GOUVERNEUR AUDIGIER
K952758 · Ets Gouverneur-Audigier · Aug 1995
ROYAL FLASH
K952939 · Royal Flash Enterprise Co. , Ltd. · Aug 1995
K951801 · MING-YA OPTICAL INDUSTRIALCO., LTD.
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