FDA.reportPublic FDA data

Thermage

Primary DI
00850608002308
Brand
Thermage
Company
SOLTA MEDICAL
Model
TTNS3.00C1-200
Catalog number
TTNS3.00C1-200
Device description
TREATMENT TIP, NON-STERILE, TC, 3.00CM2, 200 REP
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850608002308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850608002308008506080023088506080023080850608002308

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring system applicator tipA removable endpiece that is attached to a radio-frequency (RF) skin contouring system applicator (handpiece), used to regulate the delivery of RF energy to the patient during treatment. As a procedural safety measure, the device may permit the transfer of energy only when a correct surface contact is established. It may also be used to cool the skin and monitor its temperature to protect the epidermis during treatment. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079999584
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816995027850Fraxel FTXMC-BURNPAPER-LMC-BURNPAPER-L2026-07-20
00816995027867Fraxel FTXMC7MM24MC7MM242026-07-20
00816995027874Fraxel FTXMC15MM24MC15MM242026-07-20
00816995027904Fraxel FTXMCSYSFTX-LOANERMCSYSFTX-LOANER2026-07-20
00816995027461CLEAR+BRILLIANT TOUCHCBT-CONSOLE-RCBT-CONSOLE-R2020-09-01
00816995027478CLEAR+BRILLIANT TOUCHCBT-HP-1440-RCBT-HP-1440-R2020-09-01
00816995027485CLEAR+BRILLIANT TOUCHCBT-HP-1927-RCBT-HP-1927-R2020-09-01
00816995027317CLEAR+BRILLIANT TOUCHCBT-HP-1440CBT-HP-14402020-07-13
00816995027324CLEAR+BRILLIANT TOUCHCBT-HP-1927CBT-HP-19272020-07-13
00816995027331CLEAR+BRILLIANT TOUCHCBT-KEY-12CBT-KEY-122020-07-13
00850608002476PowerX Lipo System110-0020110-00202016-09-23
00850608002544PowerX Lipo System110-0039110-00392016-09-23
00816995020233Fraxel re:store DUAL Laser SystemMC-SYS-SR1500-D-USMC-SYS-SR1500-D-US2016-09-23
00816995026921PowerX Lipo System110-0020R110-0020R2017-12-14
00816995026990PowerX Lipo System110-0039R110-0039R2017-12-14
00816995027010Fraxel re:store DUAL Laser SystemMC-SYS-SR1500-D-USRMC-SYS-SR1500-D-USR2017-12-14
00816995027300CLEAR+BRILLIANT TOUCHCBT-CONSOLECBT-CONSOLE2020-07-13
00816995027799Fraxel FTXMCSYSFTX-RMCSYSFTX-R2025-04-02
00816995027805Fraxel FTXMCSYSFTXMCSYSFTX2025-04-02
00816995027249THERMAGETF-3-60TF-3-602019-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841019124178KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-28
00810140063236RENPHO Foot MassagerJoicom CorporationISA2026-10-27
00810140063243RENPHO Foot MassagerJoicom CorporationISA2026-10-27
00841019124161KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00841019124239KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00190776439774MilleniumAvalign Technologies, Inc.GEI2026-10-26
10884521783829LigaSureCovidien LPGEI2026-10-23
00190776436858MillenniumAvalign Technologies, Inc.GEI2026-10-22
06974958310631mitoredlightShenzhen Idea Light LimitedISA2026-10-22
B382SD77105560Surgical DirectSurgical Direct, Inc.GEI2026-10-22
00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
00190776435769MillenniumAvalign Technologies, Inc.GEI2026-10-21
00841019124192KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-21
00810140063229Renpho RejuvenJoicom CorporationISA2026-10-20
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17