Cleared Traditional

K941084 - SUNGLASSES

K941084 is an FDA 510(k) clearance for SUNGLASSES, manufactured by Blue Gem Sunglasses, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 524-day FDA review.

K941084 · Blue Gem Sunglasses, Inc. · Ophthalmic device
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Aug 1995
Decision
524d
Days
Class 1
Risk

K941084 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 Blue Gem Sunglasses, Inc. (Carpinteria, US). The FDA issued a Cleared decision on August 14, 1995 after a review of 524 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 Blue Gem Sunglasses, Inc. devices

FDA 510(k) Submission Details - K941084

510(k) Number K941084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1994
Decision Date August 14, 1995
Days to Decision 524 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
414d slower than avg
Panel avg: 110d · This submission: 524d
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 K941084.
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PHOTOCHROMIC LENS
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K890081 · Roseburg SA · Mar 1989
ASSENAT-BLESCHET SUNGLASSES
K885275 · Roseburg SA · Jan 1989