Cleared Traditional

K960289 - JAMES KOREA OPTICAL FRAMES & SUNGLASSES

K960289 is an FDA 510(k) clearance for JAMES KOREA OPTICAL FRAMES & SUNGLASSES, manufactured by James Korea Co., Ltd.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K960289 · James Korea Co., Ltd. · Ophthalmic device
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Feb 1996
Decision
25d
Days
Class 1
Risk

K960289 is an FDA 510(k) clearance for the JAMES KOREA OPTICAL FRAMES & SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by James Korea Co., Ltd. (Miami, US). The FDA issued a Cleared decision on February 16, 1996 after a review of 25 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 James Korea Co., Ltd. devices

FDA 510(k) Submission Details - K960289

510(k) Number K960289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1996
Decision Date February 16, 1996
Days to Decision 25 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
85d faster than avg
Panel avg: 110d · This submission: 25d
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 K960289.
BUFFARD CREATION (SUNGLASSES)
K955933 · Buffard Creation Eurl · Mar 1996
ARNET OR ARNETTE
K960530 · Arnet Optic Illusions · Mar 1996
LANARD, RADIO SHADES, SUN SHADES, COOL SHADES, KOOL LOOPS, SOLAR SPEX, SHADE ZONE
K960628 · Lanard Toys, Ltd. · Mar 1996
ZONG RONG SUNGLASSES
K955287 · Yuu Yeng Enterprise Co., Ltd. · Jan 1996
ZONG RONG SUNGLASSES
K955441 · Zong Rong Glasses Ltd. Co. · Jan 1996
PLASTIC FRAME, METAL FRAME, OPTICAL
K955695 · Dah Sing Trading Co. · Jan 1996