Atlas FDA

GWE

49 FDA 510(k) clearances · Product code

115 daysmedian time to decision
432 days90th percentile
49clearances measured

FDA profile

Official device name
Stimulator, Photic, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1890
Medical specialty
Neurology
Flags
Third-party review eligible
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
E3 and Profile (K221471)Diagnosys, LLC2022-11-22
Vision Monitor- MonCvONE (K212936)Metrovision2022-11-21
LED PHOTIC System (K211974)Micromed S.P.A.2021-09-23
Vision Monitor - MonpackONE (K211643)Metrovision2021-07-26
Nurochek System (K200705)Cryptych Pty, Ltd.2020-04-23
Natus Photic Stimulator (K173936)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2018-06-15
RETeval Visual Electrodiagnostic Device (K142567)Lkc Technologies, Inc.2015-05-19
ADHERENT VISUAL STIMULATOR GOGGLES (K113785)Anschel Technology, Inc.2012-06-06
VISIONSEARCH 1 (K120104)Visionsearch Pty, Ltd.2012-05-21
DIOPSYS NOVA VEP VISION TESTING SYSTEM (K101763)Diopsys, Inc.2011-05-09
LIFELINES PHOTIC STIMULATOR (K101691)Lifelines , Ltd.2010-08-10
NEUCODIA (K081591)Verisci Corporation2009-05-15
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE (K043367)Lace Electronica S.R.L.2005-11-17
ENFANTTM (K043491)Diopsys, Inc.2005-03-16
RETISCAN, RETIPORT (K023525)Roland Consult2004-03-26
ACCUMAP AUTOMATIC PERIMETER (K022304)Objectivision Pty , Ltd.2003-11-14
XLTEK LED GOGGLES, MODEL LED-01 (K011794)Excel Tech. , Ltd.2001-10-01
DA VINCHI EMG/EP ISA1004EP (K001467)Airsep Corp.2000-08-01
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) (K991903)Excel Tech. , Ltd.1999-08-04
KILOWIN (K971214)Cadwell Laboratories, Inc.1998-06-11
TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 (K932571)Tomey Corporation USA1995-08-31
ADVANTAGE EP (K903734)Clark Davis Medical Systems, Inc.1991-07-22
FATIGMETER (K883914)K. Jimbo Co., Inc.1989-10-31
TECA/MEDELEC MISTRAL (K880593)Teca, Inc.1988-04-06
PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL (K874136)Bio-Logic Systems Corp.1988-03-25
MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM (K872725)Eyetronics, Inc.1987-08-14
TECA NEUROPTO WITH OS-5 STIMULATOR (K861069)Teca, Inc.1987-01-27
V100 VISUALLY EVOKED POTENTIAL MONITOR (K860910)New Potentials, Inc.1986-12-18
MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) (K860801)Cadwell Laboratories, Inc.1986-11-18
MACULOSCOPE(TM) (K863956)Doran Instruments, Inc.1986-11-13
MODIFIED BRAIN ATLAS III (K854362)Bio-Logic Systems Corp.1986-04-22
L.E.D. GOGGLES, MODEL 580-LEDGOG (K852533)Bio-Logic Systems Corp.1985-12-12
WAVE GATE (K853412)Wolfline Corp.1985-10-28
VPS 2250, CSU2250 & VFU 2250 (K844659)Madsen Electronics (Canada) , Ltd.1985-02-25
SIEGEN VISUAL STIMULATOR (K844616)Siegen Corp.1985-02-14
PHOTIC STIMULATOR TM-3030-70 (K842964)Tracor Northern, Inc.1984-12-28
SLS 3500 LED VISUAL STIMULATOR (K842381)Nihon Kohden America, Inc.1984-11-09
LED STIMULATOR LS-05 (K834442)Teca, Inc.1984-08-08
EVOKED POTENTIAL SYSTEM 2000 (K831651)Ophthalmetric Corp.1983-09-12
EVOKED 3500 POTENTIAL SYSTEM (K832084)Tracor Northern, Inc.1983-08-16
BIOLOGIC SYSTEM BL 101 (K831047)Bio-Logic Systems Corp.1983-05-13
MODEL S10VS VISUAL STIMULATOR (K812061)Grass Instrument Co.1981-08-20
VISUAL PATTERN REVERSAL GEN. & PHOTIC S. (K810481)Amplaid USA, Inc.1981-03-11
ESG-1 (EVOKED RESPONSE STIMULUS GENER) (K801671)Neurodiagnostics, Inc.1980-08-04
STIMULATOR MODEL SSS-1101 (K791149)Nihon Kohden America, Inc.1979-09-17
STIMULATOR, NIC-106 VISUAL (K790570)Nicolet Biomedical Instruments1979-05-23
GENERATOR, MODEL VG-1 (K790217)Street Electronics Corp.1979-02-06
MODEL 7320 VISUAL STIMULATOR (K781461)Life-Tech Instruments, Inc.1978-11-08
TECA VS6 VIDEO STIMULATOR (K781398)Teca, Inc.1978-08-23

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Every clearance here is in the API, with alerts when new ones post.