Cleared Traditional

K965125 - DAKOTA SMITH, NICOLE MILLER SUNGLASSES

K965125 is an FDA 510(k) clearance for DAKOTA SMITH, manufactured by California Design Studio, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K965125 · California Design Studio, Inc. · Ophthalmic device
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Mar 1997
Decision
86d
Days
Class 1
Risk

K965125 is an FDA 510(k) clearance for the DAKOTA SMITH, NICOLE MILLER SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by California Design Studio, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 86 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 California Design Studio, Inc. devices

FDA 510(k) Submission Details - K965125

510(k) Number K965125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date March 19, 1997
Days to Decision 86 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
24d faster than avg
Panel avg: 110d · This submission: 86d
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 K965125.
ARROW COMPANY
K971326 · Excel Eyewear Corp. · May 1997
STYLE EYES OPTICS
K970744 · Anti-Ray, Inc. · Mar 1997
VICTORY EYEWEAR CO
K970538 · Victory Eyewear Co., Ltd. · Mar 1997
ROCCOBAROCCO & PRO-DYNAMIX
K965170 · Michelangelo, Inc. · Mar 1997
JAMES ALEX SUNGLASSES
K970101 · D&K Stores, Inc. · Mar 1997
SUNGLASSES (NON-PRESCRIPTION)
K964943 · Micron Eyewear Manufactory Co., Ltd. · Feb 1997