FDA.reportPublic FDA data

Tissue Temp Probe

Primary DI
37340007000721
Brand
Tissue Temp Probe
Company
Clinical Laserthermia Systems AB
Model
3004-02
Published
2022-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142216000Tranberg CLS Thermal Therapy SystemClinical Laserthermia Systems, AB2015-04-21GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37340007000721PackageGS15In Commercial Distribution
17340007000727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3734000700072137340007000721
1734000700072717340007000727

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
774856749
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17340007000840Laser Applicator Non-cooled4012-N52022-10-28
17340007000857Laser Applicator Non-cooled4017-N22022-10-28
17340007000864Laser Applicator Non-cooled4017-N42022-10-28
17340007000956MR Introducer4013-N62024-05-07
17340007000826Mobile Laser Unit1001-N22022-10-28
17340007000833Thermoguide Workstation1100-N12022-10-28
17340007000659Tissue Temp Probe3001-012022-10-28
17340007000666Tissue Temp Probe3001-022022-10-28
17340007000673Tissue Temp Probe3002-012022-10-28
17340007000680Tissue Temp Probe3002-022022-10-28
17340007000697Tissue Temp Probe3003-012022-10-28
17340007000703Tissue Temp Probe3003-022022-10-28
17340007000710Tissue Temp Probe3004-012022-10-28
17340007000727Tissue Temp Probe3004-022022-10-28
17340007000611Mobile Laser Unit1001-022022-10-28
17340007000871Instructions for use Tranberg Thermoguide Therapy System - USL-2019-0622022-10-28
17340007000017Mobile Laser Unit1001-012016-09-18
17340007000024Tissue Temp Probe3101-012016-09-18
17340007000031Tissue Temp Probe3101-022016-09-18
17340007000048Tissue Temp Probe3201-012016-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800291820200DermaVCynosure Lutronic Technology CorporationGEX2026-06-23
08800291820040CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820057CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820187CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820460HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820477HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820484HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820859PICOPLUSCynosure Lutronic Technology CorporationGEX2026-06-22
06973511890177SANOBeijing Sano Lasers S&T Development Co., Ltd.GEX2026-06-10
008164690216981150-500LASER PERIPHERALS, LLCGEX2026-06-08
G866ELITELT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
00647529004722Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
00647529004777Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00850064466027FREDDOFABINJECT LLCGEX2024-10-28
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
00860007603761Sentient ManufacturingSentient Manufacturing, LLCGEX2022-09-16
00860007603747Sentient ManufacturingSentient Manufacturing, LLCGEX2022-09-16