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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (10) Massager, Therapeutic, Electric (ISA) (10)

Premarket Exempt

No Yes

Clear

Thermage - 00850608002360 Catalog Number : TTNS3.00C2-900

Device Description : TREATMENT TIP, NON-STERILE, STC, 3.00CM2, 900 REP

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002377 Catalog Number : TTNS3.00C3-400

Device Description : TREATMENT TIP,NON-STERILE,STC FRAMED, 3.00CM2, 400

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002384 Catalog Number : TTNS3.00C3-600

Device Description : TREATMENT TIP,NON-STERILE,STC FRAMED, 3.00CM2, 600

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002391 Catalog Number : TTNS3.00C3-900

Device Description : TREATMENT TIP,NON-STERILE,STC FRAMED, 3.00CM2, 900

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002407 Catalog Number : TTNS3.00E2-1200

Device Description : TREATMENT TIP, NON-STERILE, DC, 3.00CM2, 1200 REP

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002414 Catalog Number : TTNS3.00E2-900

Device Description : TREATMENT TIP, NON-STERILE, DC, 3.00CM2, 900 REP

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002421 Catalog Number : TTNS3.00E4-1200

Device Description : TREATMENT TIP, NON-STERILE,3.00CM2 DC, FRAME, 1200

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002438 Catalog Number : TTNS3.00E4-400

Device Description : TREATMENT TIP, NON-STERILE, 3.00CM2 DC, FRAME,400

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002445 Catalog Number : TTNS3.00E4-900

Device Description : TREATMENT TIP, NON-STERILE, 3.00CM2 DC, FRAME, 900

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002452 Catalog Number : TW-1

Device Description : FOOTSWITCH

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : No

Device Count : 1

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