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) (5) Powered Laser Surgical Instrument With Microbeam\Fractional Output (ONG) (4) Powered Laser Surgical Instrument (GEX) (1)

Premarket Exempt

No Yes

Clear

Clear & Brilliant - 00850608002674 Catalog Number : CB-HP-1440-R

Device Description : REFURBISHED CLEAR AND BRILLIANT HANDPIECE 1440

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONG

Prescription Use : Yes

Device Count : 1

Clear & Brilliant - 00850608002681 Catalog Number : CB-HP-1927-R

Device Description : REFURBISHED CLEAR AND BRILLIANT HANDPIECE 1927

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONG

Prescription Use : Yes

Device Count : 1

Clear & Brilliant - 00850608002698 Catalog Number : CB-TIP-SC

Device Description : TIP, CLEAR+BRILLIANT

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONG

Prescription Use : Yes

Device Count : 1

Clear & Brilliant - 00850608002704 Catalog Number : CB-TIP-SCP

Device Description : TIP, CLEAR+BRILLIANT, PERMEA

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONG

Prescription Use : Yes

Device Count : 1

Fraxel - 00850608002711 Catalog Number : MC-F2-RT1ES

Device Description : TIP, SM EXT ROLLER, FRAXEL, DOM

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ORIGINS - 00850608002735 Catalog Number : 830-HDASLULK

Device Description : HANDLE, ASPIRATION, LUER LOCK

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

ORIGINS - 00850608002742 Catalog Number : 830-HDASTMSY

Device Description : TOOMEY SYRINGE ASPIR. HANDLE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

ORIGINS - 00850608002759 Catalog Number : 830-HDASVXPL

Device Description : VENTX SWIVEL HANDLE, PLASTIC

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

ORIGINS - 00850608002766 Catalog Number : 830-HDFNCNTR

Device Description : INFILTRATION HANDLE W/ON-OFF

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

ORIGINS - 00850608002773 Catalog Number : 830-HDFNSTND

Device Description : STANDARD INFILTRATION HANDLE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

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