FDA.report

10THERMA / XTHERMA

Primary DI
08809709380534
Brand
10THERMA / XTHERMA
Company
TENTECH Inc.
Model
TIP TMFT5.0-600/ XMFT5.0-600
Device description
10THERMA / XTHERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
Published
2026-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K232992000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K23299200010THERMATentech, Inc.2023-12-20GEI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809709380534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809709380534088097093805348809709380534

GMDN Terms

TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.

Sterilization Methods

Method

Regulatory Flags

DUNS number
693713346
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
0880970938047310THERMA / XTHERMATIP TMET0.25-300/ XMET0.25-3002026-02-27
0880970938048010THERMA / XTHERMATIP TMET0.25-600/ XMET0.25-6002026-02-27
0880970938049710THERMA / XTHERMATIP TMFT4.0-300/ XMFT4.0-3002026-02-27
0880970938050310THERMA / XTHERMATIP TMFT4.0-600/ XMFT4.0-6002026-02-27
0880970938051010THERMA / XTHERMATIP TMFT4.0-900/ XMFT4.0-9002026-02-27
0880970938052710THERMA / XTHERMATIP TMFT5.0-300/ XMFT5.0-3002026-02-27
0880970938054110THERMA / XTHERMATIP TMFT5.0-900/ XMFT5.0-9002026-02-27
0880970938055810THERMA / XTHERMATIP TMBT20.0-500/ XMBT20.0-5002026-02-27
0880970938056510THERMA / XTHERMATIP TMBT20.0-1000/ XMBT20.0-10002026-02-27
0880970938034310THERMATMSY022024-06-28
0880970938035010THERMATMHP022024-06-28
0880970938041110PL10PL-Body2024-06-28
0880970938043510PL10PL-H/P2024-06-28
08809709380459XTHERMAXTHERMA-Body2024-06-25
08809709380466XTHERMAXTHERMA-H/P2024-06-25

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10850067560316LaproSacSurgical Principals, IncGEI2026-05-22
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00845854035590CONCEPTConmed CorporationGEI2026-03-24
00190776417932MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776417956MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418076MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418281MillenniumAvalign Technologies, Inc.GEI2026-03-23
00653405013924CONMEDConmed CorporationGEI2026-03-23
00198506089732ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
00198506089749ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
08800020101525POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108166DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108173DENSITYJeisys Medical Inc.GEI2026-03-16
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08800020108197DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108203DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108289DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108272DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108296DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108302DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108319DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108326DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108395POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108401POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108425POTENZAJeisys Medical Inc.GEI2026-03-16
00198506089565ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-13
10884450587796STAR™Merit Medical Systems, Inc.GEI2026-03-11
10884450587802STAR™Merit Medical Systems, Inc.GEI2026-03-11
08800020107299POTENZA TipJeisys Medical Inc.GEI2026-03-10
B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09