Cleared Traditional

SUNGLASS GALLERY INC. SUNGLASS (K934407) - FDA 510(k) Clearance

Class I Ophthalmic device.

K934407 · Sunglass Gallery, Inc. · Ophthalmic device
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Apr 1994
Decision
214d
Days
Class 1
Risk

K934407 is an FDA 510(k) clearance for the SUNGLASS GALLERY INC. SUNGLASS. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Sunglass Gallery, Inc. (Chang-Hwa, Taiwan, TW). The FDA issued a Cleared decision on April 11, 1994 after a review of 214 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sunglass Gallery, Inc. devices

Submission Details

510(k) Number K934407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1993
Decision Date April 11, 1994
Days to Decision 214 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
104d slower than avg
Panel avg: 110d · This submission: 214d
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.