FDA.reportPublic FDA data

Thermage

Primary DI
00850608002162
Brand
Thermage
Company
SOLTA MEDICAL
Model
TF-2-60
Catalog number
TF-2-60
Device description
COUPLING FLUID 60ML
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850608002162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850608002162008506080021628506080021620850608002162

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring systemAn assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00816995027256THERMAGETF-3-30TF-3-302019-11-08
00850608002124ThermageTG-2BTG-2B2016-09-23
00850608002131ThermageTC-1-4TC-1-42016-09-23
00850608002148ThermageTC-2-4TC-2-42016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
00190776421755MillenniumAvalign Technologies, Inc.GEI2026-06-24
00813527028590E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028613E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028637E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028651E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028675E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028699E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028712E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028736E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028750E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028774E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028798E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028811E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028835E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028859E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028873E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028897E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028910E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527029153E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
B112S03086NSU200STINGRAY SURGICAL PRODUCTSSTINGRAY SURGICAL PRODUCTS L.L.C.GEI2026-06-10
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09