Cleared Traditional

SUNGLASSES (K941084) - FDA 510(k) Clearance

Class I Ophthalmic device.

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

Submission Details

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.

Device Classification

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.