Cleared Traditional

K872786 - SUNGLASSES

K872786 is an FDA 510(k) clearance for SUNGLASSES, manufactured by Quality Sunglasses, Ltd.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 405-day FDA review.

K872786 · Quality Sunglasses, Ltd. · Ophthalmic device
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Aug 1988
Decision
405d
Days
Class 1
Risk

K872786 is an FDA 510(k) clearance for the SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Quality Sunglasses, Ltd. (Phoenix, MU). The FDA issued a Cleared decision on August 22, 1988 after a review of 405 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Quality Sunglasses, Ltd. devices

FDA 510(k) Submission Details - K872786

510(k) Number K872786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1987
Decision Date August 22, 1988
Days to Decision 405 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
295d slower than avg
Panel avg: 110d · This submission: 405d
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 124
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K872786.
PHOTOCHROMIC LENS
K890725 · Ppg Industries, Inc. · Apr 1989
CALIUS-ISABEL CANOVAS SUNGLASSES
K890081 · Roseburg SA · Mar 1989
ASSENAT-BLESCHET SUNGLASSES
K885275 · Roseburg SA · Jan 1989
SUNGLASSES (NON-PRESCRIPTION)
K860953 · Roseburg SA · Oct 1986
RAY-BAN SUN GLASSES
K791499 · Bausch & Lomb, Inc. · Aug 1979