NEW STAR LASERS, INC.

NEW STAR LASERS, 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

Powered Laser Surgical Instrument (GEX) (10)

Premarket Exempt

No

Clear

StoneLight 30 - 00859932006006 Catalog Number : NS3000

Device Description : Ho:YAG Laser System

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

StoneLight 15 - 00859932006013 Catalog Number : NS1800

Device Description : Ho:YAG Laser System

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch CTEV - 00859932006020 Catalog Number : NS160

Device Description : Nd:YAG Laser System

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch ReNew - 00859932006037 Catalog Number : LC225

Device Description : Nd:YAG Laser System

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch CoolLipo - 00859932006044 Catalog Number : NS160

Device Description : Nd:YAG Laser System

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch SaphFire - 00859932006051 Catalog Number :

Device Description : Fiber Optic Catheter

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch SaphFire - 00859932006068 Catalog Number :

Device Description : Fiber Optic Catheter

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch EZ Pass 400 - 00859932006075 Catalog Number :

Device Description : Fiber Optic Catheter

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch - 00859932006082 Catalog Number :

Device Description : Fiber Optic Catheter

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch - 00859932006099 Catalog Number :

Device Description : Fiber Optic Catheter

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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