Cleared Traditional

K932802 - SPECTACLE FRAME

K932802 is an FDA 510(k) clearance for SPECTACLE FRAME, manufactured by Insight Optical Mfg. Co. of Florida, Inc.. The device is a Class 1 Ophthalmic device with product code HQZ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K932802 · Insight Optical Mfg. Co. of Florida, Inc. · Ophthalmic device
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Sep 1993
Decision
92d
Days
Class 1
Risk

K932802 is an FDA 510(k) clearance for the SPECTACLE FRAME. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Insight Optical Mfg. Co. of Florida, Inc. (Hialeah, US). The FDA issued a Cleared decision on September 9, 1993 after a review of 92 days - within the typical 510(k) review window.

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 Insight Optical Mfg. Co. of Florida, Inc. devices

FDA 510(k) Submission Details - K932802

510(k) Number K932802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1993
Decision Date September 09, 1993
Days to Decision 92 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
18d faster than avg
Panel avg: 110d · This submission: 92d
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 K932802.
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