Cleared Traditional

K791112 - LIBCO 1,2,3, EYEGLASS FRAMES

K791112 is an FDA 510(k) clearance for LIBCO 1, manufactured by Libco Eyewear, Inc.. The device is a Class 1 Ophthalmic device with product code HQZ cleared through the Traditional 510(k) pathway .

K791112 · Libco Eyewear, Inc. · Ophthalmic device
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Jun 1979
Decision
-
Days
Class 1
Risk

K791112 is an FDA 510(k) clearance for the LIBCO 1,2,3, EYEGLASS FRAMES. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Libco Eyewear, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979.

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.

FDA 510(k) Submission Details - K791112

510(k) Number K791112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1979
Decision Date June 15, 1979
Days to Decision -
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
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 197
Devices cleared under the same product code (HQZ) and FDA review panel - the closest regulatory comparables to K791112.
ULTRA-WIDE SAFETY SPECTACLE FRAME
K813156 · Zee Medical Products Co., Inc. · Dec 1981
SPECTACLE FRAMES
K810876 · Fashionline Corp. · Sep 1981
EYEGLASS FRAMES
K810278 · Caesar Intl. Designs · Apr 1981
SPECTACLE FRAMES
K790266 · Alva-Tech, Inc. · Apr 1979
SPECTACLE FRAME, OP-TITE
K772368 · Dentsply Intl. · Jan 1978
EYEGLASS FRAMES
K772204 · Logo Paris, Inc. · Jan 1978
K791112 · LIBCO 1,2,3, EYEGLASS FRAMES
Download PDF Libco Eyewear, Inc.