Cleared Traditional

K925224 - U108, U105, G209-B

K925224 is an FDA 510(k) clearance for U108, manufactured by Custom Optical Frames, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K925224 · Custom Optical Frames, Inc. · Ophthalmic device
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Sep 1993
Decision
320d
Days
Class 1
Risk

K925224 is an FDA 510(k) clearance for the U108, U105, G209-B. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Custom Optical Frames, Inc. (Rockville, US). The FDA issued a Cleared decision on September 1, 1993 after a review of 320 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 Custom Optical Frames, Inc. devices

FDA 510(k) Submission Details - K925224

510(k) Number K925224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1992
Decision Date September 01, 1993
Days to Decision 320 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
210d slower than avg
Panel avg: 110d · This submission: 320d
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 60
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K925224.
GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES
K964505 · I C Optics, Ltd. · Jan 1997
SUNGLASSES OR MULTIPLE
K964429 · Trade Resources , Ltd. · Dec 1996
SUNGLASSES(NON-PRESCRIPTION)
K964413 · Ever Prime Enterprises , Ltd. · Nov 1996
PHOTOCHROMIC LENS
K890725 · Ppg Industries, Inc. · Apr 1989
CALIUS-ISABEL CANOVAS SUNGLASSES
K890081 · Roseburg SA · Mar 1989
ASSENAT-BLESCHET SUNGLASSES
K885275 · Roseburg SA · Jan 1989