Cleared Traditional

K120104 - VISIONSEARCH 1

K120104 is an FDA 510(k) clearance for VISIONSEARCH 1, manufactured by Visionsearch Pty, Ltd.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K120104 · Visionsearch Pty, Ltd. · Neurology device
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May 2012
Decision
129d
Days
Class 2
Risk

K120104 is an FDA 510(k) clearance for the VISIONSEARCH 1. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Visionsearch Pty, Ltd. (St Leonards, AU). The FDA issued a Cleared decision on May 21, 2012 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Visionsearch Pty, Ltd. devices

FDA 510(k) Submission Details - K120104

510(k) Number K120104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2012
Decision Date May 21, 2012
Days to Decision 129 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 148d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWE Stimulator, Photic, Evoked Response

All 24
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