Cleared Traditional

K923374 - VARIOUS SUNGLASSES

K923374 is an FDA 510(k) clearance for VARIOUS SUNGLASSES, manufactured by Playtime Products, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 335-day FDA review.

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.

FDA 510(k) Submission Details - K923374

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
225d slower than avg
Panel avg: 110d · This submission: 335d
Pathway characteristics
Predicate-based equivalence.

HQY Device Classification - Class 1, General Controls

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.

Regulatory Peers - HQY Sunglasses (non-prescription Including Photosensitive)

All 628
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K923374.
NON-PRES SUNGLASSES/SPEC FRAMES (PLASTIC & METAL)
K925736 · Eyeworks 3 · Jun 1993
SERIOUS SKINGLASSES
K922120 · Serious Skinglasses · Jun 1993
MMELALENS SUNGLASSES
K923746 · Dwh, Inc. · Jun 1993
PLAYSKOOL SUNGLASSES
K923375 · Playtime Products, Inc. · Jun 1993
SUNGLASSES
K923778 · Cyrk Intl., Inc. · Jun 1993
XENO MELANIN LENS
K924548 · Photoprotective Technologies · Apr 1993
K923374 · VARIOUS SUNGLASSES
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