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

Massager, Vacuum, Radio Frequency Induced Heat (PBX) (6) Powered Laser Surgical Instrument (GEX) (5) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2)

Premarket Exempt

Clear

CoolView - 00816722022325 Catalog Number :

Device Description : CoolView Laser Handpiece for EV+ (EV2)

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dermastat - 00816722022349 Catalog Number :

Device Description : Dermastat 2mm Handpiece for EV+

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Genesis V - 00816722022356 Catalog Number :

Device Description : Genesis V Laser Handpiece for EV+

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CoolView - 00816722022363 Catalog Number :

Device Description : CoolView Laser Handpiece for EV+ (EV3)

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

truSculpt 16 - 00816722022400 Catalog Number :

Device Description : truSculpt 16 RF Handpiece

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

truSculpt 25 - 00816722022417 Catalog Number :

Device Description : truSculpt 25 RF Handpiece

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

truSculpt 40 - 00816722022424 Catalog Number :

Device Description : truSculpt 40 RF Handpiece

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

truSculpt 3D - 00816722022431 Catalog Number :

Device Description : truSculpt 3D RF Handpiece

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEX, PBX

Prescription Use : Yes

Device Count : 1

truSculpt 16 Hand Held - 00816722022448 Catalog Number :

Device Description : truSculpt 16 Hand Held RF Handpiece for iD

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : Yes

Device Count : 1

truSculpt 40 Hand Held - 00816722022455 Catalog Number :

Device Description : truSculpt 40 Hand Held RF Handpiece for iD

Device Class : 2

Duns Number: 041071643

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : Yes

Device Count : 1

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