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 For Removal (QPB) (6) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (3) Massager, Therapeutic, Electric (ISA) (3)

Premarket Exempt

No Yes

Clear

Thermage - 00850608002889 Catalog Number : TH-4R

Device Description : HANDPIECE, CPT (REFURB)

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEI, ISA

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002896 Catalog Number : TH-3R

Device Description : HANDPIECE, NXT, 16.0 (REFURB)

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEI, ISA

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002902 Catalog Number : TH-2R

Device Description : HANDPIECE, NXT (REFURB)

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEI, ISA

Prescription Use : Yes

Device Count : 1

VASER - 00850608002926 Catalog Number : 130-0171

Device Description : CANNULA,LONG 4.6 SST 6 CURVED

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : QPB

Prescription Use : Yes

Device Count : 1

VASER - 00850608002933 Catalog Number : 130-0524

Device Description : CANNULA, 4.6MM, 26CM, ANGLED

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : QPB

Prescription Use : Yes

Device Count : 1

VASER - 00850608002940 Catalog Number : 130-0525

Device Description : CANNULA, 3.0MM, 26CM, CURVED

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : QPB

Prescription Use : Yes

Device Count : 1

VASER - 00850608002957 Catalog Number : 130-0526

Device Description : CANNULA, 3.0MM, 26CM,SWAN NECK

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : QPB

Prescription Use : Yes

Device Count : 1

VASER - 00850608002988 Catalog Number : 130-0562

Device Description : CANNULA,3MMX20CM,CURVED

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : QPB

Prescription Use : Yes

Device Count : 1

VASER - 00850608002995 Catalog Number : 130-0563

Device Description : CANNULA,3MMX26CM,CURVED

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : QPB

Prescription Use : Yes

Device Count : 1

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