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 Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (7) Powered Laser Surgical Instrument (GEX) (3)

Premarket Exempt

No Yes

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Fraxel - 00816995020417 Catalog Number : MC-RE:PAIR-NO-SPATULA

Device Description : Fraxel re:pair barrel without

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020424 Catalog Number : IS2-HANDPIECE

Device Description : ISOLAZ 2 SYSTEM, HANDPIECE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020431 Catalog Number : IS2-CONSOLE-R

Device Description : ISOLAZ 2, CONSOLE, REFURBISHED

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020448 Catalog Number : IS2-CONSOLE

Device Description : ISOLAZ 2 SYSTEM, CONSOLE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020455 Catalog Number : 30-01685

Device Description : ASSEMBLY, AMGLO LAMP, ISOLAZ

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020462 Catalog Number : IS2-CATIP

Device Description : TIP, CALIBRATION, ISOLAZ 2

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020479 Catalog Number : IS2-CART-220-R

Device Description : ISOLAZ 2, CART-220, REFURBISHED

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020486 Catalog Number : IS2-CART-220

Device Description : ISOLAZ 2 SYSTEM, CART-220

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020493 Catalog Number : 40-01230

Device Description : SM ISR ST I-IV 500

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020509 Catalog Number : IS2-CART-110-R

Device Description : ISOLAZ 2, CART-110, REFURBISHED

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

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