Cleared Traditional

K952939 - ROYAL FLASH

K952939 is an FDA 510(k) clearance for ROYAL FLASH, manufactured by Royal Flash Enterprise Co. , Ltd.. 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.

K952939 · Royal Flash Enterprise Co. , Ltd. · Ophthalmic device
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Aug 1995
Decision
42d
Days
Class 1
Risk

K952939 is an FDA 510(k) clearance for the ROYAL FLASH. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Royal Flash Enterprise Co. , Ltd. (Tainan City, TW). The FDA issued a Cleared decision on August 7, 1995 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.

FDA 510(k) Submission Details - K952939

510(k) Number K952939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1995
Decision Date August 07, 1995
Days to Decision 42 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
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 645
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K952939.
MING-YA OPTICAL INDUSTRIALCO., LTD.
K951801 · Min-Ya Optical Industrial Co., Ltd. · Aug 1995
HENNERT SA
K952734 · Hennert S.A. · Aug 1995
GOUVERNEUR AUDIGIER
K952758 · Ets Gouverneur-Audigier · Aug 1995
OPTX 20/20
K953413 · Neoptx, Inc. · Aug 1995
SUNGLASSES (NON-PRESCRIPTION)
K953473 · Cbi Dist. · Aug 1995
HURRICANE
K952258 · Hurricane Hardware, Inc. · Jul 1995
K952939 · ROYAL FLASH
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