ISOLUX LLC

Address:1045 COLLIER CENTER WAY,NAPLES,FL,34110,US

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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

Illuminator, Fiberoptic, Surgical Field (HBI) (1) Laparoscope, Gynecologic (And Accessories) (HET) (1) Light, Surgical, Fiberoptic (FST) (1)

Premarket Exempt

Clear

1300XSB - 00852350007006 Catalog Number : 03-1300XSB

Device Description : 300 Watt Xenon Illuminator Used For Surgical Instrument Illumination.

Device Class : 2

Duns Number: 828730973

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

Isolux llc - 00852350007013 Catalog Number : 05-09WS

Device Description : Bifurcated Fiber Optic Headlight Cable, Wolf, Lensed, 3.8mm x 8.5ft, Long ACMI

Device Class : 2

Duns Number: 828730973

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

OptiLux LED Illuminator - 00852350007020 Catalog Number :

Device Description : LED Illuminator Used For Surgical Instrument Illumination

Device Class : 2

Duns Number: 828730973

Premarket Exempt : No

Product Code : HBI

Prescription Use : Yes

Device Count : 1

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