CUTERA, INC.

CUTERA, INC.

Address:3240 BAYSHORE BLVD,BRISBANE,CA,94005,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

Powered Laser Surgical Instrument (GEX) (9) Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (PDZ) (1) Massager, Therapeutic, Electric (ISA) (1) Massager, Vacuum, Light Induced Heating (NUV) (1) Massager, Vacuum, Radio Frequency Induced Heat (PBX) (1)

Premarket Exempt

No

Clear

CoolGlide CV - 00816722021007 Catalog Number :

Device Description : CoolGlide CV Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolGlide Excel - 00816722021014 Catalog Number :

Device Description : CoolGlide Excel Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolGlide Vantage - 00816722021021 Catalog Number :

Device Description : CoolGlide Vantage Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolGlide Genesis - 00816722021038 Catalog Number :

Device Description : CoolGlide Genesis Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

xeo - 00816722021106 Catalog Number :

Device Description : xeo Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

xeo SA - 00816722021113 Catalog Number :

Device Description : xeo SA IPL System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Genesis Plus - 00816722021205 Catalog Number :

Device Description : Genesis Plus Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : PDZ, GEX

Prescription Use : Yes

Device Count : 1

excel V - 00816722021304 Catalog Number :

Device Description : excel V Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

excel V+ - 00816722021311 Catalog Number :

Device Description : excel V+ Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

truSculpt - 00816722021403 Catalog Number :

Device Description : truSculpt RF Device

Device Class : 1

Duns Number: 041071643

Premarket Exempt : No

Product Code : PBX, NUV, ISA

Prescription Use : Yes

Device Count : 1

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