Cleared Traditional

K932125 - OPTICAL ACCESSORIES-SPECTACLE FRAMES AND SUNGLASSES

K932125 is an FDA 510(k) clearance for OPTICAL ACCESSORIES-SPECTACLE FRAMES AN..., manufactured by Vision Design Eyewear, Inc.. The device is a Class 1 Ophthalmic device with product code HQZ cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K932125 · Vision Design Eyewear, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K932125

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.

HQZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - HQZ Frame, Spectacle

All 7
Devices cleared under the same product code (HQZ) and FDA review panel - the closest regulatory comparables to K932125.
OPTHALMIC WIPE
K942897 · Surgin Surgical Instrumentation, Inc. · Aug 1994
SPECTACLE FRAME - DANIELLE
K871688 · Roseburg SA · May 1987
SPECTACLE FRAME - LORRAINE
K871689 · Roseburg SA · May 1987
EYE BARRIER
K863182 · O.R. Concepts, Inc. · Sep 1986
SPECTACLES FRAME
K860954 · Roseburg SA · Mar 1986
SPECTACLE FRAME, OP-TITE
K772368 · Dentsply Intl. · Jan 1978