Cleared Traditional

K962298 - CENTER OPTICAL GLASSES

K962298 is an FDA 510(k) clearance for CENTER OPTICAL GLASSES, manufactured by Mirage Eyewear, Inc.. 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.

K962298 · Mirage Eyewear, Inc. · Ophthalmic device
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Jul 1996
Decision
42d
Days
Class 1
Risk

K962298 is an FDA 510(k) clearance for the CENTER OPTICAL GLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Mirage Eyewear, Inc. (Alhambra, US). The FDA issued a Cleared decision on July 25, 1996 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.

View all Mirage Eyewear, Inc. devices

FDA 510(k) Submission Details - K962298

510(k) Number K962298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1996
Decision Date July 25, 1996
Days to Decision 42 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
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 123
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K962298.
MARCELLA CARAN
K962912 · Framesmart, Inc. · Aug 1996
FITO DIDO
K963075 · Framesmart, Inc. · Aug 1996
EAGLE EYES SUNGLASSES
K962287 · Positive Response Television · Aug 1996
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD.
K962382 · Xiamen Chingsong Optical Industrial Co., Ltd. · Jul 1996
(BRAND NAME) SUNGLASS FRAMES
K962478 · Custom Optical Frames, Inc. · Jul 1996
SUNGLASSES, GAUDI SUN LINE
K962636 · Gaudi Spa · Jul 1996