Cleared Traditional

K971875 - OPTIM-EYES 450

K971875 is an FDA 510(k) clearance for OPTIM-EYES 450, manufactured by Taylor/Fox Enterprises, LLC. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K971875 · Taylor/Fox Enterprises, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
24d
Days
Class 1
Risk

K971875 is an FDA 510(k) clearance for the OPTIM-EYES 450. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Taylor/Fox Enterprises, LLC (Washington, US). The FDA issued a Cleared decision on June 13, 1997 after a review of 24 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 Taylor/Fox Enterprises, LLC devices

FDA 510(k) Submission Details - K971875

510(k) Number K971875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1997
Decision Date June 13, 1997
Days to Decision 24 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 110d · This submission: 24d
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 62
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K971875.
RIVIERA SUNGLASS4ES
K972194 · Riviera Optical Co., Ltd. · Jun 1997
SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC)
K971087 · W.J. Byrnes & Co. of Los Angeles, Inc. · Jun 1997
SUNGLASSES (NON-PRESCRIPTION)
K971707 · Niko Sunglasses Corp. · Jun 1997
GLARE WARE
K970816 · Ergovision, Inc. · Jun 1997
DUQIAO
K971551 · Duqiao Glasses (Group) Co. , Ltd. · Jun 1997
PATHFINDER SUNGLASSES
K971495 · Coil · May 1997