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

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (OHV) (5) System, Suction, Lipoplasty (MUU) (3) Powered Laser Surgical Instrument (GEX) (2)

Premarket Exempt

No Yes

Clear

VASER - 00816995020103 Catalog Number : 130-0561

Device Description : PROBE - 2.9MM, 26CM, 2G

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00816995020110 Catalog Number : 130-0560

Device Description : PROBE - 2.9MM, 18CM, 2G

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

VASER - 00816995020127 Catalog Number : 130-0559

Device Description : PROBE - 2.9MM, 11CM, 2G

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

Fraxel - 00816995020134 Catalog Number : MC-RS-SOC-ACC

Device Description : SOC TIP ACCESSORIES

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Liposonix - 00816995020141 Catalog Number : P006392-03

Device Description : INSTALLATION KIT, MODEL 2, GENERIC, P2.1

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : OHV

Prescription Use : Yes

Device Count : 1

Liposonix - 00816995020158 Catalog Number : P006530-04

Device Description : CARTRIDGE, REPLACEABLE TREATMENT

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : OHV

Prescription Use : Yes

Device Count : 1

Fraxel - 00816995020165 Catalog Number : MC-SYS-ACC-RP

Device Description : RE:PAIR ACC KIT

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Liposonix - 00816995020172 Catalog Number : P006472-05

Device Description : TREATMENT KIT,EXT. USE, 1.3CM, WORLDWIDE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : OHV

Prescription Use : Yes

Device Count : 1

Liposonix - 00816995020189 Catalog Number : P006373-05

Device Description : TREATMENT KIT, 1.3CM, WORLDWIDE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : OHV

Prescription Use : Yes

Device Count : 1

Liposonix - 00816995020196 Catalog Number : P006145-01

Device Description : HANDPIECE, REPLACEMENT, P2.X

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : OHV

Prescription Use : Yes

Device Count : 1

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