Cleared Traditional

K934459 - MED-GENESIS PATIENT LASER EYE SHIELD (FDA 510(k) Clearance)

Class I Radiology device.

K934459 · Med-Genesis, Inc. · Radiology device
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Feb 1994
Decision
165d
Days
Class 1
Risk

K934459 is an FDA 510(k) clearance for the MED-GENESIS PATIENT LASER EYE SHIELD. Classified as Shield, Eye, Radiological (product code IWS), Class I - General Controls.

Submitted by Med-Genesis, Inc. (Great Neck,, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 165 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.6500 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Med-Genesis, Inc. devices

Submission Details

510(k) Number K934459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1993
Decision Date February 22, 1994
Days to Decision 165 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 107d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWS Shield, Eye, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.6500
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.