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 - 00850608002261 Catalog Number : TTNS0.25NB1-225

Device Description : TREATMENT TIP, NON-STERILE, ST, 0.25CM2, 225 REP

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002278 Catalog Number : TTNS0.25NB1-450

Device Description : TREATMENT TIP, NON-STERILE, ST, 0.25CM2, 450 REP

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002285 Catalog Number : TTNS16.00E2-400

Device Description : TREATMENT TIP, NON-STERILE, BODY,16.00CM2, 400 REP

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002292 Catalog Number : TTNS16.00E2-500

Device Description : TREATMENT TIP, NON-STERILE, BODY,16.00CM2, 500 REP

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002308 Catalog Number : TTNS3.00C1-200

Device Description : TREATMENT TIP, NON-STERILE, TC, 3.00CM2, 200 REP

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002315 Catalog Number : TTNS3.00C1-300

Device Description : TREATMENT TIP, NON-STERILE, TC, 3.00CM2, 300 REP

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002322 Catalog Number : TTNS3.00C1-400

Device Description : TREATMENT TIP, NON-STERILE, TC, 3.00CM2, 400 REP

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002339 Catalog Number : TTNS3.00C1-600

Device Description : TREATMENT TIP, NON-STERILE, TC, 3.00CM2, 600 REP

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002346 Catalog Number : TTNS3.00C1-900

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

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

Thermage - 00850608002353 Catalog Number : TTNS3.00C2-600

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

Device Class : 1

Duns Number: 079999584

Premarket Exempt : No

Product Code : ISA, GEI

Prescription Use : Yes

Device Count : 1

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