Product Code: GWE FDA class 2 21 CFR 882.1890

Stimulator, Photic, Evoked Response

Neurology

The Stimulator, Photic, Evoked Response is a neurological device that delivers controlled flashes of light to a patient to elicit visual evoked potentials (VEPs), which are recorded to assess the functional integrity of the visual pathways in the brain. It is an FDA Class 2 device, indicating moderate risk and requiring 510(k) premarket clearance. The product code is GWE, regulated under 21 CFR 882.1890 in the Neurology specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code GWE in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: GWE
Device Class: FDA class 2
Regulation Number: 882.1890
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 49 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K221471	E3 and Profile	Nov 22, 2022	Substantially Equivalent	Diagnosys, LLC
K212936	Vision Monitor- MonCvONE	Nov 21, 2022	Substantially Equivalent	Metrovision
K211974	LED PHOTIC System	Sep 23, 2021	Substantially Equivalent	Micromed S.P.A.
K211643	Vision Monitor - MonpackONE	Jul 26, 2021	Substantially Equivalent	Metrovision
K200705	Nurochek System	Apr 23, 2020	Substantially Equivalent	Cryptych Pty, Ltd.
K173936	Natus Photic Stimulator	Jun 15, 2018	Substantially Equivalent	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K142567	RETeval Visual Electrodiagnostic Device	May 19, 2015	Substantially Equivalent	Lkc Technologies, Inc.
K113785	ADHERENT VISUAL STIMULATOR GOGGLES	Jun 06, 2012	Substantially Equivalent	Anschel Technology, Inc.
K120104	VISIONSEARCH 1	May 21, 2012	Substantially Equivalent	Visionsearch Pty, Ltd.
K101763	DIOPSYS NOVA VEP VISION TESTING SYSTEM	May 09, 2011	Substantially Equivalent	Diopsys, Inc.
K101691	LIFELINES PHOTIC STIMULATOR	Aug 10, 2010	Substantially Equivalent	Lifelines , Ltd.
K081591	NEUCODIA	May 15, 2009	Substantially Equivalent	Verisci Corporation
K043367	GLAID OCULAR ELECTROPHYSIOLOGY DEVICE	Nov 17, 2005	Substantially Equivalent	Lace Electronica S.R.L.
K043491	ENFANTTM	Mar 16, 2005	Substantially Equivalent	Diopsys, Inc.
K023525	RETISCAN, RETIPORT	Mar 26, 2004	Substantially Equivalent	Roland Consult
K022304	ACCUMAP AUTOMATIC PERIMETER	Nov 14, 2003	Substantially Equivalent	Objectivision Pty , Ltd.
K011794	XLTEK LED GOGGLES, MODEL LED-01	Oct 01, 2001	Substantially Equivalent	Excel Tech. , Ltd.
K001467	DA VINCHI EMG/EP ISA1004EP	Aug 01, 2000	Substantially Equivalent	Airsep Corp.
K991903	EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)	Aug 04, 1999	Substantially Equivalent	Excel Tech. , Ltd.
K971214	KILOWIN	Jun 11, 1998	Substantially Equivalent	Cadwell Laboratories, Inc.
K932571	TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4	Aug 31, 1995	Substantially Equivalent	Tomey Corporation USA
K903734	ADVANTAGE EP	Jul 22, 1991	Substantially Equivalent	Clark Davis Medical Systems, Inc.
K883914	FATIGMETER	Oct 31, 1989	Substantially Equivalent	K. Jimbo Co., Inc.
K880593	TECA/MEDELEC MISTRAL	Apr 06, 1988	Substantially Equivalent	Teca, Inc.
K874136	PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL	Mar 25, 1988	Substantially Equivalent	Bio-Logic Systems Corp.
K872725	MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM	Aug 14, 1987	Substantially Equivalent	Eyetronics, Inc.
K861069	TECA NEUROPTO WITH OS-5 STIMULATOR	Jan 27, 1987	Substantially Equivalent	Teca, Inc.
K860910	V100 VISUALLY EVOKED POTENTIAL MONITOR	Dec 18, 1986	Substantially Equivalent	New Potentials, Inc.
K860801	MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)	Nov 18, 1986	Substantially Equivalent	Cadwell Laboratories, Inc.
K863956	MACULOSCOPE(TM)	Nov 13, 1986	Substantially Equivalent	Doran Instruments, Inc.
K854362	MODIFIED BRAIN ATLAS III	Apr 22, 1986	Substantially Equivalent	Bio-Logic Systems Corp.
K852533	L.E.D. GOGGLES, MODEL 580-LEDGOG	Dec 12, 1985	Substantially Equivalent	Bio-Logic Systems Corp.
K853412	WAVE GATE	Oct 28, 1985	Substantially Equivalent	Wolfline Corp.
K844659	VPS 2250, CSU2250 & VFU 2250	Feb 25, 1985	Substantially Equivalent	Madsen Electronics (Canada) , Ltd.
K844616	SIEGEN VISUAL STIMULATOR	Feb 14, 1985	Substantially Equivalent	Siegen Corp.
K842964	PHOTIC STIMULATOR TM-3030-70	Dec 28, 1984	Substantially Equivalent	Tracor Northern, Inc.
K842381	SLS 3500 LED VISUAL STIMULATOR	Nov 09, 1984	Substantially Equivalent	Nihon Kohden America, Inc.
K834442	LED STIMULATOR LS-05	Aug 08, 1984	Substantially Equivalent	Teca, Inc.
K831651	EVOKED POTENTIAL SYSTEM 2000	Sep 12, 1983	Substantially Equivalent	Ophthalmetric Corp.
K832084	EVOKED 3500 POTENTIAL SYSTEM	Aug 16, 1983	Substantially Equivalent	Tracor Northern, Inc.
K831047	BIOLOGIC SYSTEM BL 101	May 13, 1983	Substantially Equivalent	Bio-Logic Systems Corp.
K812061	MODEL S10VS VISUAL STIMULATOR	Aug 20, 1981	Substantially Equivalent	Grass Instrument Co.
K810481	VISUAL PATTERN REVERSAL GEN. & PHOTIC S.	Mar 11, 1981	Substantially Equivalent	Amplaid USA, Inc.
K801671	ESG-1 (EVOKED RESPONSE STIMULUS GENER)	Aug 04, 1980	Substantially Equivalent	Neurodiagnostics, Inc.
K791149	STIMULATOR MODEL SSS-1101	Sep 17, 1979	Substantially Equivalent	Nihon Kohden America, Inc.
K790570	STIMULATOR, NIC-106 VISUAL	May 23, 1979	Substantially Equivalent	Nicolet Biomedical Instruments
K790217	GENERATOR, MODEL VG-1	Feb 06, 1979	Substantially Equivalent	Street Electronics Corp.
K781461	MODEL 7320 VISUAL STIMULATOR	Nov 08, 1978	Substantially Equivalent	Life-Tech Instruments, Inc.
K781398	TECA VS6 VIDEO STIMULATOR	Aug 23, 1978	Substantially Equivalent	Teca, Inc.