Cleared Traditional

K972490 - D'ARC EYE CARE SUNGLASSES

K972490 is an FDA 510(k) clearance for D'ARC EYE CARE SUNGLASSES, manufactured by M & R Dist.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K972490 · M & R Dist. · Ophthalmic device
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Jul 1997
Decision
23d
Days
Class 1
Risk

K972490 is an FDA 510(k) clearance for the D'ARC EYE CARE SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by M & R Dist. (Los Angeles, US). The FDA issued a Cleared decision on July 25, 1997 after a review of 23 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 M & R Dist. devices

FDA 510(k) Submission Details - K972490

510(k) Number K972490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1997
Decision Date July 25, 1997
Days to Decision 23 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
87d faster than avg
Panel avg: 110d · This submission: 23d
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 K972490.
NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS
K973016 · Optimaxx Intl. · Sep 1997
RUFF WORK EYEGEAR
K972717 · Ruff House, Inc. · Aug 1997
NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES
K972590 · Lbi U.S.A. · Jul 1997
MOMO DESIGN OR MOMO
K972416 · Momo U.S.A., Inc. · Jul 1997
SUNGLASSES
K971385 · Kosway Industries Co., Ltd. · Jul 1997
FOVS, BRILLARTE, ETC...
K972362 · Sunglass City, Inc. · Jul 1997