Cleared Traditional

K962636 - SUNGLASSES, GAUDI SUN LINE

K962636 is an FDA 510(k) clearance for SUNGLASSES, manufactured by Gaudi Spa. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K962636 · Gaudi Spa · Ophthalmic device
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Jul 1996
Decision
20d
Days
Class 1
Risk

K962636 is an FDA 510(k) clearance for the SUNGLASSES, GAUDI SUN LINE. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Gaudi Spa (Oviedo, US). The FDA issued a Cleared decision on July 25, 1996 after a review of 20 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 Gaudi Spa devices

FDA 510(k) Submission Details - K962636

510(k) Number K962636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1996
Decision Date July 25, 1996
Days to Decision 20 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
90d faster than avg
Panel avg: 110d · This submission: 20d
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 K962636.
CENTER OPTICAL GLASSES
K962298 · Mirage Eyewear, Inc. · Jul 1996
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD.
K962382 · Xiamen Chingsong Optical Industrial Co., Ltd. · Jul 1996
(BRAND NAME) SUNGLASS FRAMES
K962478 · Custom Optical Frames, Inc. · Jul 1996
SOMA
K962725 · Soma International , Ltd. · Jul 1996
SUNGLASSES (NON-PRESCRIPTION)
K962775 · Canadd Trading Co. · Jul 1996
NON-GENERIC
K962310 · Classic Elegance Intl., Inc. · Jul 1996