GWE · Stimulator, Photic, Evoked Response
Neurology · 21 CFR 882.1890 · Class 2
Overview
| Product Code | GWE |
|---|---|
| Device Name | Stimulator, Photic, Evoked Response |
| Regulation | 21 CFR 882.1890 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | E3 and Profile | Diagnosys, LLC | Nov 22, 2022 | SESE |
| K212936 | Vision Monitor- MonCvONE | Metrovision | Nov 21, 2022 | SESE |
| K211974 | LED PHOTIC System | Micromed S.P.A. | Sep 23, 2021 | SESE |
| K211643 | Vision Monitor - MonpackONE | Metrovision | Jul 26, 2021 | SESE |
| K200705 | Nurochek System | Cryptych Pty, Ltd. | Apr 23, 2020 | SESE |
| K173936 | Natus Photic Stimulator | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Jun 15, 2018 | SESE |
| K142567 | RETeval Visual Electrodiagnostic Device | Lkc Technologies, Inc. | May 19, 2015 | SESE |
| K113785 | ADHERENT VISUAL STIMULATOR GOGGLES | Anschel Technology, Inc. | Jun 6, 2012 | SESE |
| K120104 | VISIONSEARCH 1 | Visionsearch Pty, Ltd. | May 21, 2012 | SESE |
| K101763 | DIOPSYS NOVA VEP VISION TESTING SYSTEM | Diopsys, Inc. | May 9, 2011 | SESE |
| K101691 | LIFELINES PHOTIC STIMULATOR | Lifelines , Ltd. | Aug 10, 2010 | SESE |
| K081591 | NEUCODIA | Verisci Corporation | May 15, 2009 | SESE |
| K043367 | GLAID OCULAR ELECTROPHYSIOLOGY DEVICE | Lace Electronica S.R.L. | Nov 17, 2005 | SESE |
| K043491 | ENFANTTM | Diopsys, Inc. | Mar 16, 2005 | SESE |
| K023525 | RETISCAN, RETIPORT | Roland Consult | Mar 26, 2004 | SESE |
| K022304 | ACCUMAP AUTOMATIC PERIMETER | Objectivision Pty , Ltd. | Nov 14, 2003 | SESE |
| K011794 | XLTEK LED GOGGLES, MODEL LED-01 | Excel Tech. , Ltd. | Oct 1, 2001 | SESE |
| K001467 | DA VINCHI EMG/EP ISA1004EP | Airsep Corp. | Aug 1, 2000 | SESE |
| K991903 | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) | Excel Tech. , Ltd. | Aug 4, 1999 | SESE |
| K971214 | 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
