SOLTA MEDICAL

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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) (8) Powered Laser Surgical Instrument (GEX) (2)

Premarket Exempt

No Yes

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Isolaz - 00816995020301 Catalog Number : IS2-TIP-AC-M-4

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

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Fraxel - 00816995020318 Catalog Number : MC-TIP-RE:PAIR-KIT

Device Description : FRAXEL REPAIR CARTRIDGE KIT

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020325 Catalog Number : IS2-TIP-AC-M-1

Device Description : ISOLAZ 2 TREATMENT TIP, ACNE, MEDIUM, 1

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020332 Catalog Number : IS2-TIP-AC-L-4

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

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020349 Catalog Number : IS2-TIP-AC-L-1

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

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Fraxel - 00816995020356 Catalog Number : MC-TIP-RE:PAIR-KIT-SST

Device Description : FRAXEL REPAIR TIP KIT, SST

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020363 Catalog Number : IS2-LAMP-550

Device Description : LAMP, 550 NM, ISOLAZ 2

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020370 Catalog Number : IS2-LAMP-400

Device Description : LAMP, 400 NM, ISOLAZ 2

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020394 Catalog Number : IS2-KIT-ACC

Device Description : ACCESSORY KIT, ISOLAZ 2

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020400 Catalog Number : IS2-HANDPIECE-R

Device Description : ISOLAZ 2,HANDPIECE , REFURBISHED

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

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