GWE · Class II · 21 CFR 882.1890

FDA Product Code GWE: Stimulator, Photic, Evoked Response

Leading manufacturers include Teca, Inc., Bio-Logic Systems Corp. and Metrovision.

49
Total
49
Cleared
178d
Avg days
1978
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Stimulator, Photic, Evoked Response Devices (Product Code GWE)

49 devices
1–24 of 49
Cleared Nov 22, 2022
E3 and Profile
K221471
Diagnosys, LLC
Ophthalmic · 186d
Cleared Nov 21, 2022
Vision Monitor- MonCvONE
K212936
Metrovision
Ophthalmic · 432d
Cleared Sep 23, 2021
LED PHOTIC System
K211974
Micromed S.P.A.
Neurology · 90d
Cleared Jul 26, 2021
Vision Monitor - MonpackONE
K211643
Metrovision
Ophthalmic · 60d
Cleared Apr 23, 2020
Nurochek System
K200705
Cryptych Pty, Ltd.
Neurology · 36d
Cleared Jun 15, 2018
Natus Photic Stimulator
K173936
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Neurology · 171d
Cleared May 19, 2015
RETeval Visual Electrodiagnostic Device
K142567
Lkc Technologies, Inc.
Neurology · 249d
Cleared Jun 06, 2012
ADHERENT VISUAL STIMULATOR GOGGLES
K113785
Anschel Technology, Inc.
Neurology · 166d
Cleared May 21, 2012
VISIONSEARCH 1
K120104
Visionsearch Pty, Ltd.
Neurology · 129d
Cleared May 09, 2011
DIOPSYS NOVA VEP VISION TESTING SYSTEM
K101763
Diopsys, Inc.
Neurology · 320d
Cleared Aug 10, 2010
LIFELINES PHOTIC STIMULATOR
K101691
Lifelines , Ltd.
Neurology · 55d
Cleared May 15, 2009
NEUCODIA
K081591
Verisci Corporation
Neurology · 343d
Cleared Nov 17, 2005
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
K043367
Lace Electronica S.R.L.
Neurology · 344d
Cleared Mar 16, 2005
ENFANTTM
K043491
Diopsys, Inc.
Neurology · 89d
Cleared Oct 01, 2001
XLTEK LED GOGGLES, MODEL LED-01
K011794
Excel Tech. , Ltd.
Neurology · 115d
Cleared Aug 01, 2000
DA VINCHI EMG/EP ISA1004EP
K001467
Airsep Corp.
Neurology · 83d
Cleared Aug 04, 1999
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
K991903
Excel Tech. , Ltd.
Neurology · 61d
Cleared Jun 11, 1998
KILOWIN
K971214
Cadwell Laboratories, Inc.
Neurology · 435d
Cleared Apr 06, 1988
TECA/MEDELEC MISTRAL
K880593
Teca, Inc.
Neurology · 55d
Cleared Mar 25, 1988
PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
K874136
Bio-Logic Systems Corp.
Neurology · 164d
Cleared Jan 27, 1987
TECA NEUROPTO WITH OS-5 STIMULATOR
K861069
Teca, Inc.
Neurology · 313d
Cleared Nov 18, 1986
MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
K860801
Cadwell Laboratories, Inc.
Neurology · 259d
Cleared Apr 22, 1986
MODIFIED BRAIN ATLAS III
K854362
Bio-Logic Systems Corp.
Neurology · 175d
Cleared Dec 12, 1985
L.E.D. GOGGLES, MODEL 580-LEDGOG
K852533
Bio-Logic Systems Corp.
Neurology · 181d

About Product Code GWE - Regulatory Context

510(k) Submission Activity

49 total 510(k) submissions under product code GWE since 1978, with 49 receiving FDA clearance (average review time: 178 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.