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

VASER - 00850608002780 Catalog Number : 130-0116

Device Description : 3.2 mm Skin Port with Orange Disc

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002797 Catalog Number : 130-0127

Device Description : 3.2 mm Skin Port Replacement Discs

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002803 Catalog Number : 130-0110

Device Description : 3.2 mm Skin Port Plug

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002810 Catalog Number : 130-0117

Device Description : 4.6 mm Skin Port with White Disc

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002827 Catalog Number : 130-0128

Device Description : 4.6 mm Skin Port Replacement Discs

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002834 Catalog Number : 130-0112

Device Description : 4.6 mm Skin Port Plug

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002841 Catalog Number : 130-0096

Device Description : 4.6 mm Corkscrew Skin Port

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002858 Catalog Number : 130-0094

Device Description : Skin Port Incision Opener Tool

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

POWERX - 00850608002865 Catalog Number : 115-0018-D

Device Description : POWERX SYSTEM ACCESSORY KIT, DOMESTIC

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002872 Catalog Number : 115-0019-D

Device Description : VASER 2.2 FULL SYSTEM ACCESSORY KIT, DOMESTIC

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

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