Cleared Traditional

OPTICAL ACCESSORIES-SPECTACLE FRAMES AND SUNGLASSES (K932125) - FDA 510(k) Clearance

Class I Ophthalmic device.

K932125 · Vision Design Eyewear, Inc. · Ophthalmic device
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Oct 1993
Decision
151d
Days
Class 1
Risk

K932125 is an FDA 510(k) clearance for the OPTICAL ACCESSORIES-SPECTACLE FRAMES AND SUNGLASSES. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Vision Design Eyewear, Inc. (Miami, US). The FDA issued a Cleared decision on October 1, 1993 after a review of 151 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5842 - 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 Vision Design Eyewear, Inc. devices

Submission Details

510(k) Number K932125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1993
Decision Date October 01, 1993
Days to Decision 151 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
41d slower than avg
Panel avg: 110d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQZ Frame, Spectacle
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5842
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.