Cleared Traditional

SUNGLASSES (K925539) - FDA 510(k) Clearance

Class I Ophthalmic device.

K925539 · Sunshine Opticians, Inc. · Ophthalmic device
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Dec 1993
Decision
401d
Days
Class 1
Risk

K925539 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 Sunshine Opticians, Inc. (Tainan, Taiwan R.O.C., CN). The FDA issued a Cleared decision on December 8, 1993 after a review of 401 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 Sunshine Opticians, Inc. devices

Submission Details

510(k) Number K925539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1992
Decision Date December 08, 1993
Days to Decision 401 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
291d slower than avg
Panel avg: 110d · This submission: 401d
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.