Cleared Traditional

K944026 - MIRAGE EYEWEAR INC.

K944026 is an FDA 510(k) clearance for MIRAGE EYEWEAR INC., 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 28-day FDA review.

K944026 · Mirage Eyewear, Inc. · Ophthalmic device
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Sep 1994
Decision
28d
Days
Class 1
Risk

K944026 is an FDA 510(k) clearance for the MIRAGE EYEWEAR INC.. 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 September 14, 1994 after a review of 28 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 - K944026

510(k) Number K944026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1994
Decision Date September 14, 1994
Days to Decision 28 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
82d faster than avg
Panel avg: 110d · This submission: 28d
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 632
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K944026.
SUNGLASSES
K943562 · Australian Optical Co., Inc. · Sep 1994
SUNGLASS CLIP
K943640 · Australian Optical Co., Inc. · Sep 1994
NIL
K943963 · Max-Vision (H.K.)Limited · Sep 1994
NIL
K944108 · Micron Metal & Plastic Manufactory Co. · Sep 1994
NIL
K944109 · Keep Top Intl., Ltd. · Sep 1994
SUNGLASSES
K942322 · Suntory Industrial Co. · Sep 1994
K944026 · MIRAGE EYEWEAR INC.
Download PDF Mirage Eyewear, Inc.