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) (8) Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (2)

Premarket Exempt

No Yes

Clear

Isolaz - 00816995020516 Catalog Number : IS2-CART-110

Device Description : ISOLAZ 2 SYSTEM, CART-110

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020523 Catalog Number : 40-01232

Device Description : MD ISR ST I-IV 600

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020530 Catalog Number : 40-01234

Device Description : SM IAC ST I-IV 375

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020547 Catalog Number : 40-01236

Device Description : MD IAC ST I-IV 1200

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020554 Catalog Number : IS-TC-4ZE

Device Description : ISOLAZ TIP SPRAY 4 PACK, 1234ZE

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : ONF

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020561 Catalog Number : IS-TC-4

Device Description : ISOLAZ TIP SPRAY 4 PACK

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020578 Catalog Number : 40-01361

Device Description : SM IAC ST IV-VI 375

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020585 Catalog Number : 40-01363

Device Description : MD IAC ST IV-VI 1200

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020592 Catalog Number : 40-01365

Device Description : SM ISR ST IV-VI 500

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Isolaz - 00816995020608 Catalog Number : 40-01367

Device Description : MD ISR ST IV-VI 600

Device Class : 2

Duns Number: 079999584

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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