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) (2) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1) Massager, Therapeutic, Electric (ISA) (1)

Premarket Exempt

No Yes

Clear

Isolaz - 00816995020615 Catalog Number : 40-01746

Device Description : TIP, PROFUSION, MACH XL WITH SOFTWARE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020622 Catalog Number : 40-01862

Device Description : PROFUSION 1 TIP + 30C PK

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

THERMAGE FLX - 00816995020639 Catalog Number : TG-3A

Device Description : Thermage FLX RF System

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

ORIGINS - 00816995020646 Catalog Number : 810-BKBU4025SWNR

Device Description : BASKET, BULLET, 40MMX25CM, BLUE SWIVEL HANDLE, NR

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

ORIGINS - 00816995020653 Catalog Number : 820-FNBU3025LLNR

Device Description : INFILT., BULLET TIP, 30MM X 25CM, LUER LOCK, NR

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

ORIGINS - 00816995020660 Catalog Number : 130-0062

Device Description : 3.0 MM, TRIANGLE, 26 CM

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

ORIGINS - 00816995020677 Catalog Number : 130-0064

Device Description : 3.7 MM, TRIANGLE, 26 CM

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

ORIGINS - 00816995020684 Catalog Number : 130-0073

Device Description : 3.0 MM, TRIANGLE, 16.5 CM

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

ORIGINS - 00816995020691 Catalog Number : 130-0075

Device Description : 3.7 MM, TRIANGLE, 16.5 CM

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

ORIGINS - 00816995020707 Catalog Number : 130-0079

Device Description : 3.7 MM, TRIANGLE, 34.5 CM

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

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