LIGHTLAB IMAGING, INC.

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

Optical coherence tomography, intravascular catheter (ORD) (4) SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) (NQQ) (4) CATHETER, INTRAVASCULAR, DIAGNOSTIC (DQO) (3)

Premarket Exempt

No

Clear

C7 Dragonfly™ - 00183739000562 Catalog Number : 100-100-00

Device Description : Imaging Catheter

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : ORD

Prescription Use : Yes

Device Count : 1

Dragonfly™ - 00183739000623 Catalog Number : 100-100-KT

Device Description : Imaging Catheter

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : ORD

Prescription Use : Yes

Device Count : 1

ILUMIEN™ - 00183739000630 Catalog Number : 900-700-00

Device Description : Imaging System

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

Dragonfly™ - 00183739000647 Catalog Number : C408645

Device Description : Imaging Catheter

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Dragonfly™ - 00183739000654 Catalog Number : C408646

Device Description : Imaging Catheter

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

ILUMIEN™ - 00183739000678 Catalog Number : C408650

Device Description : Imaging System

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

Dragonfly™ - 00183739000692 Catalog Number : C408643

Device Description : Imaging Catheter

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : ORD

Prescription Use : Yes

Device Count : 1

Dragonfly™ - 00183739000708 Catalog Number : C408644

Device Description : Imaging Catheter

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : ORD

Prescription Use : Yes

Device Count : 1

OPTIS™ - 00183739000937 Catalog Number : C408652

Device Description : Imaging System

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ

Prescription Use : Yes

Device Count : 1

OPTIS™ - 00812059020003 Catalog Number : C408654

Device Description : Installation Kit

Device Class : 2

Duns Number: 018493531

Premarket Exempt : No

Product Code : NQQ, DQO

Prescription Use : Yes

Device Count : 1

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