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) (7) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2) Massager, Vacuum, Radio Frequency Induced Heat (PBX) (2) Lamp, Infrared, Therapeutic Heating (ILY) (1)

Premarket Exempt

Clear

truSculpt - 00816722021410 Catalog Number :

Device Description : truSculpt 2 MHz RF Device

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : Yes

Device Count : 1

truSculpt iD - 00816722021427 Catalog Number :

Device Description : truSculpt iD RF Device

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : Yes

Device Count : 1

excel HR - 00816722021502 Catalog Number :

Device Description : excel HR Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

enlighten - 00816722021601 Catalog Number :

Device Description : enlighten Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

enlighten - 00816722021618 Catalog Number :

Device Description : enlighten Low Energy Green Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

enlighten - 00816722021625 Catalog Number :

Device Description : enlighten SR Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

enlighten - 00816722021649 Catalog Number :

Device Description : enlighten III Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

AviClear - 00816722021700 Catalog Number :

Device Description : AviClear Laser System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Solera Opus - 00816722021908 Catalog Number :

Device Description : Solera Opus IPL System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Solera Titan - 00816722021915 Catalog Number :

Device Description : Solera Titan IPL System

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

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