Cleared Traditional

K971327 - UNIKA

K971327 is an FDA 510(k) clearance for UNIKA, manufactured by Eyewear Partners Co.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K971327 · Eyewear Partners Co. · Ophthalmic device
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May 1997
Decision
29d
Days
Class 1
Risk

K971327 is an FDA 510(k) clearance for the UNIKA. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Eyewear Partners Co. (Miami, US). The FDA issued a Cleared decision on May 9, 1997 after a review of 29 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 Eyewear Partners Co. devices

FDA 510(k) Submission Details - K971327

510(k) Number K971327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1997
Decision Date May 09, 1997
Days to Decision 29 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
81d faster than avg
Panel avg: 110d · This submission: 29d
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 K971327.
PATHFINDER SUNGLASSES
K971495 · Coil · May 1997
AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES
K970699 · Yeong Jiuh Corp. · May 1997
SUNGLASSES
K971412 · Team Chien Industrial Co., Ltd. · May 1997
EVEREST SUNGLASSES
K970315 · Ycc International Corp. · May 1997
LAXIMA INTERNATIONAL LIMITED SUNGLASSES
K970454 · Laxima Intl., Ltd. · May 1997
HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION)
K970476 · Hwa Mao Optical Co., Ltd. · May 1997