ULTHERA, INC.

Address:1840 South Stapley Drive Suite 200,Mesa,AZ,85204,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

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (OHV) (5) Powered Surgical Instrument For Improvement In The Appearance Of Cellulite (OUP) (5) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (3)

Premarket Exempt

Clear

Ulthera System Transducer - 00840763100339 Catalog Number :

Device Class : 2

Duns Number: 010981554

Premarket Exempt : No

Product Code : OHV, IYO

Prescription Use : No

Device Count : 1

Ulthera System Transducer - 00840763100346 Catalog Number :

Device Class : 2

Duns Number: 010981554

Premarket Exempt : No

Product Code : IYO, OHV

Prescription Use : No

Device Count : 1

Ulthera System Transducer - 00840763100353 Catalog Number :

Device Class : 2

Duns Number: 010981554

Premarket Exempt : No

Product Code : OHV

Prescription Use : No

Device Count : 1

Ulthera System Transducer - 00840763100360 Catalog Number :

Device Class : 2

Duns Number: 010981554

Premarket Exempt : No

Product Code : OHV, IYO

Prescription Use : No

Device Count : 1

Cellfina Prep Pack - 00840763100377 Catalog Number :

Device Class : 2

Duns Number: 010981554

Premarket Exempt : No

Product Code : OUP

Prescription Use : No

Device Count : 1

Cellfina Motor Module Device and Package - 00840763100384 Catalog Number :

Device Description : No change in DI justified in the CO. No form fit function, model or version cha No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI

Device Class : 2

Duns Number: 010981554

Premarket Exempt : No

Product Code : OUP

Prescription Use : No

Device Count : 1

Cellfina System Disposable Tray - 00840763100391 Catalog Number :

Device Class : 2

Duns Number: 010981554

Premarket Exempt : No

Product Code : OUP

Prescription Use : No

Device Count : 1

Cellfina System Disposable Tray - 00840763100407 Catalog Number :

Device Class : 2

Duns Number: 010981554

Premarket Exempt : No

Product Code : OUP

Prescription Use : No

Device Count : 1

Cellfina System Disposable Tray - 00840763100414 Catalog Number :

Device Class : 2

Duns Number: 010981554

Premarket Exempt : No

Product Code : OUP

Prescription Use : No

Device Count : 1

Ulthera System Handpiece - 00840763100421 Catalog Number :

Device Class : 2

Duns Number: 010981554

Premarket Exempt : No

Product Code : OHV

Prescription Use : No

Device Count : 1

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