L K C TECHNOLOGIES, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Photic, Evoked Response (GWE) (10) Pupillometer, Ac-Powered (HLG) (5) Electrode, Cutaneous (GXY) (3)

Premarket Exempt

Clear

UTAS - 00857901006422 Catalog Number :

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

RETeval™ - 00857901006439 Catalog Number : RETeval Complete

Device Description : RETeval visual electrophysiology system - Complete model for Germany

Device Class : 1

Duns Number: 606234730

Premarket Exempt : No

Product Code : HLG, GXY, GWE

Prescription Use : Yes

Device Count : 1

RETeval™ - 00857901006446 Catalog Number : RETeval Complete

Device Description : RETeval visual electrophysiology system - Complete model for China

Device Class : 1

Duns Number: 606234730

Premarket Exempt : No

Product Code : HLG, GXY, GWE

Prescription Use : Yes

Device Count : 1

RETeval™ - 00857901006453 Catalog Number : RETeval Complete

Device Description : RETeval visual electrophysiology system - Complete model for Brazil

Device Class : 1

Duns Number: 606234730

Premarket Exempt : No

Product Code : HLG, GXY, GWE

Prescription Use : Yes

Device Count : 1

RETeval™ - 00857901006460 Catalog Number : RETeval Complete

Device Description : RETeval visual electrophysiology system - Complete model w/o Electrodes

Device Class : 1

Duns Number: 606234730

Premarket Exempt : No

Product Code : HLG, GWE

Prescription Use : Yes

Device Count : 1

RETeval™ - 00857901006477 Catalog Number : RETeval Complete

Device Description : RETeval visual electrophysiology system - Complete model w/o Electrodes

Device Class : 1

Duns Number: 606234730

Premarket Exempt : No

Product Code : HLG, GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006491 Catalog Number : UTAS

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006507 Catalog Number :

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006514 Catalog Number :

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006521 Catalog Number : UTAS

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

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