FDA.reportPublic FDA data

RETeval™

Primary DI
00857901006019
Brand
RETeval™
Company
L K C TECHNOLOGIES, INC.
Model
RETeval Flicker USA
Catalog number
RETeval Flicker USA
Device description
RETeval visual electrophysiology system - Flicker model
Published
2016-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWEStimulator, Photic, Evoked Response
GXYElectrode, Cutaneous
HLGPupillometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2
GXYElectrode, CutaneousNeurology2
HLGPupillometer, Ac-PoweredOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142567000RETeval Visual Electrodiagnostic DeviceLkc Technologies, Inc.2015-05-19GWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857901006019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857901006019008579010060198579010060190857901006019

GMDN Terms#

Term, Definition table
TermDefinition
ElectroretinographAn ophthalmic device used to record the changes in electric potential on or near the surface of the cornea to a reference distal point on the body, following stimulation of the retina by light, i.e., flashes of white light. The electroretinograph (ERG) recorder is used with a primary electrode [typically gold (Au), platinum (Pt) or silver (Ag)] and a reference electrode located almost anywhere on the body, e.g., cheek or ear lobe, and an amplifier that boosts the bioelectrical potential. Some are compatible with a personal computer (PC) for waveform storage and analysis. It is used in the diagnosis of retinal degeneration, night blindness, and circulatory disturbances of the retina.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
310-840-1992support@lkc.com

Regulatory Flags#

DUNS number
606234730
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857901006354UTASUTAS System Type-642021-03-08
00857901006620RETeval™RETeval Complete - UKRAINERETeval Complete2025-07-01
00857901006637RETeval™RETeval-DR - ROWRETEval - DR2025-07-01
00857901006347UTASUTAS System Type-41UTAS2020-11-18
00857901006491UTASUTAS System Type-9LUTAS2022-06-27
00857901006507UTASUTAS System Type-10L2022-06-27
00857901006514UTASUTAS System Type-11L2022-06-27
00857901006521UTASUTAS System Type-12LUTAS2022-06-27
00857901006538UTASUTAS System Type-39L2022-06-27
00857901006545UTASUTAS System Type-40LUTAS2022-06-27
00857901006552UTASUTAS System Type-41LUTAS2022-06-27
00857901006569UTASUTAS System Type-47L2022-06-27
00857901006576UTASUTAS System Type-48LUTAS2022-06-27
00857901006590UTASUTAS System Type-52L Pattern/Multifocal/SunBurst2022-06-27
00857901006408UTASUTAS System Type-52 Pattern/Multifocal/SunBurst2022-02-04
00857901006378UTASUTAS System Type-102021-03-19
00857901006088UTASUTAS System Type-9UTAS2016-05-03
00857901006170UTASUTAS System Type-12UTAS2016-06-08
00857901006200UTASUTAS System Type-40UTAS2016-08-05
00857901006217UTASUTAS System Type-48UTAS2016-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08