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) (5) CATHETER, INTRAVASCULAR, DIAGNOSTIC (DQO) (1)

Premarket Exempt

Clear

OPTIS™ - 00812059021918 Catalog Number : E4-FULL-WW

Device Description : Software Upgrade

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

OPTIS™ - 00812059021925 Catalog Number : E4-STD-WW

Device Description : Software Upgrade

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

OPTIS™ - 00812059021987 Catalog Number : C408666

Device Description : Installation Kit

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

OPTIS™ - 00812059021994 Catalog Number : C408667

Device Description : Installation Kit

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

AptiVue™ - 05415067030856 Catalog Number : 1014666

Device Description : Software Upgrade Kit

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ, DQO

Prescription Use : Yes

Device Count : 1

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