Cleared Traditional

NONE-GENERIC (K940725) - FDA 510(k) Clearance

Class I Ophthalmic device.

K940725 · Yon'S Jay Enterprise Co. · Ophthalmic device
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Apr 1995
Decision
424d
Days
Class 1
Risk

K940725 is an FDA 510(k) clearance for the NONE-GENERIC. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Yon'S Jay Enterprise Co. (Tainan, Taiwan, TW). The FDA issued a Cleared decision on April 18, 1995 after a review of 424 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 Yon'S Jay Enterprise Co. devices

Submission Details

510(k) Number K940725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1994
Decision Date April 18, 1995
Days to Decision 424 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
314d slower than avg
Panel avg: 110d · This submission: 424d
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.