Cleared Traditional

ITEM # 754 HOT FLIP SHADES (K931389) - FDA 510(k) Clearance

Class I Ophthalmic device.

K931389 · Ja-Ru, Inc. · Ophthalmic device
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Oct 1993
Decision
202d
Days
Class 1
Risk

K931389 is an FDA 510(k) clearance for the ITEM # 754 HOT FLIP SHADES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Ja-Ru, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 6, 1993 after a review of 202 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 Ja-Ru, Inc. devices

Submission Details

510(k) Number K931389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1993
Decision Date October 06, 1993
Days to Decision 202 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
92d slower than avg
Panel avg: 110d · This submission: 202d
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.