Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1890](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1890) → GWE — Stimulator, Photic, Evoked Response # GWE · Stimulator, Photic, Evoked Response _Neurology · 21 CFR 882.1890 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE ## Overview - **Product Code:** GWE - **Device Name:** Stimulator, Photic, Evoked Response - **Regulation:** [21 CFR 882.1890](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1890) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 49) Showing 20 most recent of 49 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K221471](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K221471.md) | E3 and Profile | Diagnosys, LLC | Nov 22, 2022 | SESE | | [K212936](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K212936.md) | Vision Monitor- MonCvONE | Metrovision | Nov 21, 2022 | SESE | | [K211974](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K211974.md) | LED PHOTIC System | Micromed S.P.A. | Sep 23, 2021 | SESE | | [K211643](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K211643.md) | Vision Monitor - MonpackONE | Metrovision | Jul 26, 2021 | SESE | | [K200705](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K200705.md) | Nurochek System | Cryptych Pty, Ltd. | Apr 23, 2020 | SESE | | [K173936](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K173936.md) | Natus Photic Stimulator | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Jun 15, 2018 | SESE | | [K142567](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K142567.md) | RETeval Visual Electrodiagnostic Device | Lkc Technologies, Inc. | May 19, 2015 | SESE | | [K113785](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K113785.md) | ADHERENT VISUAL STIMULATOR GOGGLES | Anschel Technology, Inc. | Jun 6, 2012 | SESE | | [K120104](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K120104.md) | VISIONSEARCH 1 | Visionsearch Pty, Ltd. | May 21, 2012 | SESE | | [K101763](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K101763.md) | DIOPSYS NOVA VEP VISION TESTING SYSTEM | Diopsys, Inc. | May 9, 2011 | SESE | | [K101691](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K101691.md) | LIFELINES PHOTIC STIMULATOR | Lifelines , Ltd. | Aug 10, 2010 | SESE | | [K081591](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K081591.md) | NEUCODIA | Verisci Corporation | May 15, 2009 | SESE | | [K043367](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K043367.md) | GLAID OCULAR ELECTROPHYSIOLOGY DEVICE | Lace Electronica S.R.L. | Nov 17, 2005 | SESE | | [K043491](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K043491.md) | ENFANTTM | Diopsys, Inc. | Mar 16, 2005 | SESE | | [K023525](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K023525.md) | RETISCAN, RETIPORT | Roland Consult | Mar 26, 2004 | SESE | | [K022304](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K022304.md) | ACCUMAP AUTOMATIC PERIMETER | Objectivision Pty , Ltd. | Nov 14, 2003 | SESE | | [K011794](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K011794.md) | XLTEK LED GOGGLES, MODEL LED-01 | Excel Tech. , Ltd. | Oct 1, 2001 | SESE | | [K001467](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K001467.md) | DA VINCHI EMG/EP ISA1004EP | Airsep Corp. | Aug 1, 2000 | SESE | | [K991903](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K991903.md) | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) | Excel Tech. , Ltd. | Aug 4, 1999 | SESE | | [K971214](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K971214.md) | KILOWIN | Cadwell Laboratories, Inc. | Jun 11, 1998 | SESE | ## Top Applicants - Bio-Logic Systems Corp. — 4 clearances - Teca, Inc. — 4 clearances - Cadwell Laboratories, Inc. — 2 clearances - Diopsys, Inc. — 2 clearances - Excel Tech. , Ltd. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com