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

Powered Laser Surgical Instrument With Microbeam\Fractional Output (ONG) (4) System, Suction, Lipoplasty (MUU) (4) System, Suction, Lipoplasty For Removal (QPB) (2)

Premarket Exempt

No Yes

Clear

POWERX - 00850608002575 Catalog Number : 115-0018

Device Description : ACCESSORY KIT, POWERX SYSTEM

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : QPB

Prescription Use : Yes

Device Count : 1

VASER - 00850608002582 Catalog Number : 115-0019

Device Description : ACCESSORY KIT, FULL SYSTEM 2.2

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : QPB

Prescription Use : Yes

Device Count : 1

VASER - 00850608002599 Catalog Number : 130-0070

Device Description : TUBING SET, INFILTRATION,PVC

Device Class :

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002605 Catalog Number : 130-0071

Device Description : TUBING SET, SUCTION, PVC

Device Class :

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002612 Catalog Number : 130-0168

Device Description : CANISTER, 1250CC, CASE 20, VENTX

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00850608002629 Catalog Number : SHP

Device Description : VASERSMOOTH HANDPIECE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

Clear & Brilliant - 00850608002636 Catalog Number : CB-HP-1927

Device Description : CLEAR + BRILLIANT 1927 HANDPIECE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONG

Prescription Use : Yes

Device Count : 1

Clear & Brilliant - 00850608002643 Catalog Number : CB-CONSOLE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONG

Prescription Use : Yes

Device Count : 1

Clear & Brilliant - 00850608002650 Catalog Number : CB-HP-1440

Device Description : CLEAR+ BRILLIANT 1440 HANDPIECE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONG

Prescription Use : Yes

Device Count : 1

Clear & Brilliant - 00850608002667 Catalog Number : CB-CONSOLE-R

Device Description : REFURBISHED CLEAR AND BRILLIANT CONSOLE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONG

Prescription Use : Yes

Device Count : 1

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