Cleared Traditional

K964366 - EAGLE EYES

K964366 is an FDA 510(k) clearance for EAGLE EYES, manufactured by Mech-Tronic Precision Mfg., Ltd.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K964366 · Mech-Tronic Precision Mfg., Ltd. · Ophthalmic device
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Jan 1997
Decision
89d
Days
Class 1
Risk

K964366 is an FDA 510(k) clearance for the EAGLE EYES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Mech-Tronic Precision Mfg., Ltd. (Kowloon, HK). The FDA issued a Cleared decision on January 29, 1997 after a review of 89 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 Mech-Tronic Precision Mfg., Ltd. devices

FDA 510(k) Submission Details - K964366

510(k) Number K964366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date January 29, 1997
Days to Decision 89 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
21d faster than avg
Panel avg: 110d · This submission: 89d
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 56
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K964366.
JAMES ALEX SUNGLASSES
K970101 · D&K Stores, Inc. · Mar 1997
SUNGLASSES (NON-PRESCRIPTION)
K964943 · Micron Eyewear Manufactory Co., Ltd. · Feb 1997
NON-PRESCRIPTION SUNGLASSES
K965021 · Victory Eyewear Co., Ltd. · Feb 1997
SUNGLASSES
K964564 · Micron Metal & Plastic Manufactory Co. · Jan 1997
SENNA
K964744 · Trans-America Enterprises Corp. · Jan 1997
GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES
K964505 · I C Optics, Ltd. · Jan 1997