SUNOPTIC TECHNOLOGIES LLC

Address:6018 BOWDENDALE AVE.,JACKSONVILLE,FL,32216,US

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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

Light Source, Fiberoptic, Routine (FCW) (4) Headlamp, Operating, Battery-Operated (HPP) (3) Light, Surgical, Floor Standing (FSS) (2) Light, Surgical, Carrier (FSZ) (1)

Premarket Exempt

No Yes

Clear

Sunoptic Technologies - M678LED40000 Catalog Number :

Device Description : LED 4000 Lightsource

Device Class : 2

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : FCW

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678LED500 Catalog Number :

Device Description : LED 50 watt 1000 and 2000 lightsources

Device Class : 2

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : FCW

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678LED55000 Catalog Number :

Device Class : 1

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678LED80000 Catalog Number :

Device Description : LED 8000 headlight series

Device Class : 1

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678LED90000 Catalog Number :

Device Description : LED 9000 headlight series

Device Class : 1

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678ROVER0 Catalog Number :

Device Description : Rover lightsource series

Device Class : 2

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : FCW

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678SLS0 Catalog Number :

Device Description : LED Rover Disoposable, Non-Sterile Series

Device Class : 2

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : FCW

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678TITAN0 Catalog Number :

Device Description : Xenon Lightsource

Device Class : 2

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : FSS

Prescription Use : Yes

Device Count : 1

TRACLUX - M678TLC0 Catalog Number :

Device Description : TRACLUX Light Carrier, Sterile, Single Use, and accessories

Device Class : 2

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : FSZ

Prescription Use : Yes

Device Count : 1

Sunoptic Technologies - M678TX0 Catalog Number :

Device Description : Tx series Xenon Lightsource

Device Class : 2

Duns Number: 094586898

Premarket Exempt : Yes

Product Code : FSS

Prescription Use : Yes

Device Count : 1

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