Cleared Traditional

K961035 - US-HOLO SUNGLASSES

K961035 is an FDA 510(k) clearance for US-HOLO SUNGLASSES, manufactured by Mi Technologies, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K961035 · Mi Technologies, Inc. · Ophthalmic device
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Apr 1996
Decision
27d
Days
Class 1
Risk

K961035 is an FDA 510(k) clearance for the US-HOLO SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Mi Technologies, Inc. (Ardmore, US). The FDA issued a Cleared decision on April 10, 1996 after a review of 27 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 Mi Technologies, Inc. devices

FDA 510(k) Submission Details - K961035

510(k) Number K961035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1996
Decision Date April 10, 1996
Days to Decision 27 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
83d faster than avg
Panel avg: 110d · This submission: 27d
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 K961035.
OAKLEY, INC SUNGLASSES
K961268 · Oakley, Inc. · Apr 1996
SUNGLASSES OR MULTIPLE
K960890 · Outdoor Action Wear Specialties · Apr 1996
FRANCO SORDELLI SUNGLASSES
K960950 · Franco Sordelli & C. Snc · Apr 1996
NON PRESCRIPTION SUN GLASSES
K960650 · Solovision Optical, Inc. · Mar 1996
SUNGLASSES/EYEGLASS FRAMES
K960573 · Architectures · Mar 1996
FABRIS LAN SUNGLASSES
K960786 · Fabris Lane Intl., Ltd. · Mar 1996