NEOLIGHT LLC

NEOLIGHT LLC

Address:1475 N Scottsdale Rd Ste 110,Scottsdale,AZ,85257,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

Unit, Neonatal Phototherapy (LBI) (8) Pad, Neonatal Eye (FOK) (2)

Premarket Exempt

No Yes

Clear

Skylife Lightbed - 10852788008009 Catalog Number :

Device Description : Phototherapy Device

Device Class : 2

Duns Number: 074301687

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

Skylife Controller - 10852788008016 Catalog Number :

Device Description : Device Controller (with system)

Device Class : 2

Duns Number: 074301687

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

GelMat - 10852788008023 Catalog Number :

Device Description : GelMat

Device Class : 2

Duns Number: 074301687

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

CloudCover Plus - 10852788008047 Catalog Number : NL-SK-8S

Device Description : CloudCover Plus (disposable)

Device Class :

Duns Number: 074301687

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

Light Module - 10852788008054 Catalog Number :

Device Description : Light Modules (2) installed in system

Device Class : 2

Duns Number: 074301687

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

Skylife System - 10852788008078 Catalog Number :

Device Description : Phototherapy System

Device Class : 2

Duns Number: 074301687

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

Cloud Swaddle - 10852788008092 Catalog Number :

Device Description : CloudCover (disposable 5 pcs with system - labeled bag)

Device Class :

Duns Number: 074301687

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 5

GelMat Consumable - 10852788008122 Catalog Number : NL-SK-6

Device Description : Gel Mat

Device Class : 2

Duns Number: 074301687

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

Posey Eye Protection - 10852788008146 Catalog Number :

Device Description : Eye protection for newborn phototherapy - sized for small/micro premie patients

Device Class :

Duns Number: 074301687

Premarket Exempt : Yes

Product Code : FOK

Prescription Use : No

Device Count : 1

Posey Eye Protection - 10852788008153 Catalog Number :

Device Description : Eye protection for newborn phototherapy - sized for newborn patients

Device Class :

Duns Number: 074301687

Premarket Exempt : Yes

Product Code : FOK

Prescription Use : No

Device Count : 1

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