Cleared Traditional

K970476 - HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION)

K970476 is an FDA 510(k) clearance for HWA MAO OPTICAL SUNGLASSES (NON-PRESCRI..., manufactured by Hwa Mao Optical Co., Ltd.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K970476 · Hwa Mao Optical Co., Ltd. · Ophthalmic device
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May 1997
Decision
88d
Days
Class 1
Risk

K970476 is an FDA 510(k) clearance for the HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION). Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Hwa Mao Optical Co., Ltd. (Hu Li, Xiamen, CN). The FDA issued a Cleared decision on May 6, 1997 after a review of 88 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 Hwa Mao Optical Co., Ltd. devices

FDA 510(k) Submission Details - K970476

510(k) Number K970476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1997
Decision Date May 06, 1997
Days to Decision 88 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
22d faster than avg
Panel avg: 110d · This submission: 88d
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 59
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K970476.
UNIKA
K971327 · Eyewear Partners Co. · May 1997
EVEREST SUNGLASSES
K970315 · Ycc International Corp. · May 1997
LAXIMA INTERNATIONAL LIMITED SUNGLASSES
K970454 · Laxima Intl., Ltd. · May 1997
SOLAR SPECS
K970759 · Morris Rosenbloom & Co., Inc. · May 1997
CUSTOM OPTICAL SUNGLASS FRAMES
K970895 · Custom Optical Frames, Inc. · May 1997
BARAKKA, INFERNO, STERLING, AND/OR ONE
K970944 · Sentinal Importing Corp. · May 1997