Cleared Traditional

K954419 - SPECTACLE FRAMES/SUNGLASSES

K954419 is an FDA 510(k) clearance for SPECTACLE FRAMES/SUNGLASSES, manufactured by Ami Fashion. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K954419 · Ami Fashion · Ophthalmic device
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May 1996
Decision
238d
Days
Class 1
Risk

K954419 is an FDA 510(k) clearance for the SPECTACLE FRAMES/SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Ami Fashion (Daegu, KR). The FDA issued a Cleared decision on May 16, 1996 after a review of 238 days - an extended review 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: 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.

View all Ami Fashion devices

FDA 510(k) Submission Details - K954419

510(k) Number K954419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1995
Decision Date May 16, 1996
Days to Decision 238 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
128d slower than avg
Panel avg: 110d · This submission: 238d
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 K954419.
SUNGLASSES
K960818 · Visard Srl · May 1996
SUNGLASSES
K960953 · Galilee Optics · May 1996
SUNGLASSES
K961146 · Erica Optical Co. · May 1996
STUSSY SUNGLASSES/A.J. MORGAN SUNGLASSES
K961286 · Intl. Optical Mfg. Co., Ltd. · May 1996
CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY
K961746 · Eurotrends Eyewear, Inc. · May 1996
EVERGLORY SUNGLASSES
K960735 · Everglory Creations, Inc. · May 1996