Cleared Traditional

K945350 - FRAME, SPECTACLES

K945350 is an FDA 510(k) clearance for FRAME, manufactured by Taiwan Eva Industrial Co., Inc.. The device is a Class 1 Ophthalmic device with product code HQZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K945350 · Taiwan Eva Industrial Co., Inc. · Ophthalmic device
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Dec 1994
Decision
90d
Days
Class 1
Risk

K945350 is an FDA 510(k) clearance for the FRAME, SPECTACLES. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Taiwan Eva Industrial Co., Inc. (Kaohsiung, TW). The FDA issued a Cleared decision on December 13, 1994 after a review of 90 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 Taiwan Eva Industrial Co., Inc. devices

FDA 510(k) Submission Details - K945350

510(k) Number K945350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1994
Decision Date December 13, 1994
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
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 K945350.
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