Cleared Traditional

VARIOUS SUNGLASSES (K923374) - FDA 510(k) Clearance

Class I Ophthalmic device.

K923374 · Playtime Products, Inc. · Ophthalmic device
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Jun 1993
Decision
335d
Days
Class 1
Risk

K923374 is an FDA 510(k) clearance for the VARIOUS SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Playtime Products, Inc. (Washington, US). The FDA issued a Cleared decision on June 9, 1993 after a review of 335 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Playtime Products, Inc. devices

Submission Details

510(k) Number K923374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1992
Decision Date June 09, 1993
Days to Decision 335 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
225d slower than avg
Panel avg: 110d · This submission: 335d
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.