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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 149d · 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 Consultant

Tuv Sud America, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWE Stimulator, Photic, Evoked Response

All 43
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K120104.
Natus Photic Stimulator
K173936 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Jun 2018
RETeval Visual Electrodiagnostic Device
K142567 · Lkc Technologies, Inc. · May 2015
ADHERENT VISUAL STIMULATOR GOGGLES
K113785 · Anschel Technology, Inc. · Jun 2012
DIOPSYS NOVA VEP VISION TESTING SYSTEM
K101763 · Diopsys, Inc. · May 2011
LIFELINES PHOTIC STIMULATOR
K101691 · Lifelines , Ltd. · Aug 2010
NEUCODIA
K081591 · Verisci Corporation · May 2009
K120104 · VISIONSEARCH 1
Download PDF FDA Summary Visionsearch Pty, Ltd.