FDA.reportPublic FDA data

RETeval™

Primary DI
10857901006009
Brand
RETeval™
Company
L K C TECHNOLOGIES, INC.
Model
Sensor Strips
Catalog number
Sensor Strips
Device description
Box of 50 pairs (1-right & 1-left per pair) of electrodes for use with the RETeval visual electrophysiology system.
Published
2016-03-04
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
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

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
10857901006009PrimaryGS10
00857901006002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085790100600910857901006009
00857901006002008579010060028579010060020857901006002

GMDN Terms#

Term, Definition table
TermDefinition
Electroretinograph electrodeA non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
606234730
Device count
50
Lot or batch
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