LIGHTLAB IMAGING, 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

SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) (NQQ) (10) CATHETER, INTRAVASCULAR, DIAGNOSTIC (DQO) (1)

Premarket Exempt

Clear

OPTIS™ - 00812059020126 Catalog Number : C408653

Device Description : Mobile Workstation

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

ILUMIEN™ - 00812059020560 Catalog Number : 100111860

Device Description : Software Upgrade Kit

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

Ilumien™ - 00812059021338 Catalog Number : C408660

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ, DQO

Prescription Use : Yes

Device Count : 1

ILUMIEN™ - 00812059021383 Catalog Number : C408656

Device Description : Software Upgrade Kit

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

OPTIS™ - 00812059021390 Catalog Number : C408657

Device Description : Software Upgrade Kit

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

OPTIS™ - 00812059021420 Catalog Number : C408661

Device Description : Imaging System

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

OPTIS™ - 00812059021437 Catalog Number : C408662

Device Description : Upgrade Kit

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

OPTIS™ - 00812059021444 Catalog Number : C408663

Device Description : Tableside Controller

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

ILUMIEN™ - 00812059021482 Catalog Number : 100074942

Device Description : Software Upgrade Kit

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

C7-XR™ - 00812059021536 Catalog Number : 15211-01

Device Description : Software Upgrade Kit

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

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