SOLTA MEDICAL

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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

System, Suction, Lipoplasty (MUU) (10)

Premarket Exempt

No Yes

Clear

POWERX - 00850608002476 Catalog Number : 110-0020

Device Description : PowerX System

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002483 Catalog Number : 110-0021

Device Description : VASER 2.2

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002490 Catalog Number : 110-0022

Device Description : VENTX

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002506 Catalog Number : 110-0032

Device Description : VASER PRO AMPLIFIER

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002513 Catalog Number : 110-0035

Device Description : VASER AMPLIFIER V2, 220V

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002520 Catalog Number : 110-0036

Device Description : VENTX CONSOLE V2, 220V

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002537 Catalog Number : 110-0037

Device Description : VASER PRO AMPLIFIER, 220V

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002544 Catalog Number : 110-0039

Device Description : POWERX, 220V

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002551 Catalog Number : VHP

Device Description : VASER HANDPIECE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

POWERX - 00850608002568 Catalog Number : XHP

Device Description : POWERX Handpiece

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

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