SOLTA MEDICAL

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) (7) Powered Laser Surgical Instrument (GEX) (3)

Premarket Exempt

No Yes

Clear

Fraxel - 00816995020004 Catalog Number : MC-F2-RT1L

Device Description : TIP, LG ROLLER, FRAXEL, DOM

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

VASER - 00816995020011 Catalog Number : P007721-01

Device Description : NOSE CONE KIT

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00816995020028 Catalog Number : P007008-01

Device Description : WIRELESS FOOT SWITCH RECEIVER KIT

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00816995020035 Catalog Number : P007007-01

Device Description : WIRELESS FOOT SWITCH KIT

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

Fraxel - 00816995020042 Catalog Number : MC-RS-CA

Device Description : FRAXEL HANDPIECE COOLING ADAPTER

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

VASER - 00816995020059 Catalog Number : 130-0587

Device Description : PROBE - 2.9MM, 26CM, 5G

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00816995020066 Catalog Number : 130-0586

Device Description : PROBE - 2.9MM, 18CM, 5G

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

Fraxel - 00816995020073 Catalog Number : MC-RS-CRTL-US

Device Description : FRAXEL RESTORE COOL ROLLER TIP - 1 LARG

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

VASER - 00816995020080 Catalog Number : 130-0575

Device Description : PROBE - 3.7MM, 33CM, 5G

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00816995020097 Catalog Number : 130-0574

Device Description : PROBE - 3.7MM, 26CM, 5G

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

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