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) (7)

Premarket Exempt

Clear

New Star Lasers - 00859932006242 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 - 00859932006259 Catalog Number :

Device Description : Pullback Device

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch - 00859932006266 Catalog Number :

Device Description : Pullback Device

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch - 00859932006297 Catalog Number :

Device Description : Cryogen Cooling

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch - 00859932006303 Catalog Number :

Device Description : Cryogen Cooling

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch - 00859932006310 Catalog Number :

Device Description : Pullback Device

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolTouch - 00859932006327 Catalog Number :

Device Description : Pullback Device

Device Class : 2

Duns Number: 877266163

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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