FDA.reportPublic FDA data

10THERMA

Primary DI
08809709380350
Brand
10THERMA
Company
TENTECH Inc.
Model
TMHP02
Device description
10THERMA Handpiece
Published
2024-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232992000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K23299200010THERMATentech, Inc.2023-12-20GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809709380350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809709380350088097093803508809709380350

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
693713346
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
0880970938053410THERMA / XTHERMATIP TMFT5.0-600/ XMFT5.0-6002026-02-27
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
0880970938041110PL10PL-Body2024-06-28
0880970938043510PL10PL-H/P2024-06-28
08809709380459XTHERMAXTHERMA-Body2024-06-25
08809709380466XTHERMAXTHERMA-H/P2024-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405922MillenniumAvalign Technologies, Inc.GEI2026-07-26
00190776405939MillenniumAvalign Technologies, Inc.GEI2026-07-26
00841019123959KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123966KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123973KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123980KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123997KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00190776405809MillenniumAvalign Technologies, Inc.GEI2026-07-24
00841019123867KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-24
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17