FDA.reportPublic FDA data

RETeval™

Primary DI
00857901006040
Brand
RETeval™
Company
L K C TECHNOLOGIES, INC.
Model
RETeval Complete
Catalog number
RETeval Complete
Device description
RETeval visual electrophysiology system - Complete 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
00857901006040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857901006040008579010060408579010060400857901006040

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.

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
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
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08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
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08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
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08720791378424Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378431Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378448Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08