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 (GEX) (4) Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (4) Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (OHV) (2)

Premarket Exempt

No Yes

Clear

Liposonix - 00816995020202 Catalog Number : P005875-02

Device Description : ASSEMBLY, HANDPIECE, P2.X

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : OHV

Prescription Use : Yes

Device Count : 1

Liposonix - 00816995020219 Catalog Number : P005999-05

Device Description : SYSTEM, WIFI, LIPOSONIX, P2.1.1

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : OHV

Prescription Use : Yes

Device Count : 1

Fraxel - 00816995020226 Catalog Number : MC-SYS-ACC-RS/RF

Device Description : RE:STORE/RE:FINE ACC KIT

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Fraxel - 00816995020233 Catalog Number : MC-SYS-SR1500-D-US

Device Description : RE: STORE DUAL

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020240 Catalog Number : IS2-TIP-PFKIT-12

Device Description : ISOLAZ 2 TIP, PROFUSION KIT, 12-PK

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020257 Catalog Number : IS2-TIP-AC-SC-12

Device Description : ISOLAZ 2 TREATMENT TIP, ACNE, CREDIT, 12

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Fraxel - 00816995020264 Catalog Number : MC-TIP-RE:PAIR-4L

Device Description : FRAXEL REPAIR TIPS (4-LARGE)

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020271 Catalog Number : IS2-TIP-AC-S-4

Device Description : ISOLAZ 2 TIP, ACNE, SMALL, 4-PK

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Fraxel - 00816995020288 Catalog Number : MC-TIP-RE:PAIR-4S

Device Description : FRAXEL RE:PAIR TIPS (4-SMALL)

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020295 Catalog Number : IS2-TIP-AC-S-1

Device Description : ISOLAZ 2 TREATMENT TIP, ACNE, SMALL, 1 E

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

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