FDA.reportPublic FDA data

TFX-LT2000 Therapy Light

Primary DI
00086001245602
Brand
TFX-LT2000 Therapy Light
Company
ToeFX Inc
Model
TFX-LT2000
Device description
Light therapy device for onychomycosis
Published
2024-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDZLasers For Temporary Increase Of Clear Nail In Patients With OnychomycosisGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00086001245602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00086001245602000860012456020860012456020086001245602

GMDN Terms#

Term, Definition table
TermDefinition
Nail laser phototherapy unitA portable, mains electricity (AC-powered), laser-emitting device intended to treat nail fungal infection (onychomycosis) using low-level laser treatment (LLLT). It typically consists of an electronic unit with a digital display and a treatment platform where the foot/hand is placed to receive LLLT; it typically includes protective eyewear. It is intended to be used by a healthcare provider in a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
202099070
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012465019FungalBlueTFX-CTS2025-12-03
00860012465033RedReviveTFX LT1000N2025-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALPDZ2026-02-18
07898786930047ONE FDAVYDENCE MEDICALPDZ2026-02-18
06974214160802SIRONAWuhan Dimed Laser Technology Co., Ltd.PDZ2025-10-16
06974214160789REMYWuhan Dimed Laser Technology Co., Ltd.PDZ2025-10-14
16977331780035GIGAAGigaalaser Company Ltd.PDZ2025-08-13
00817495024653GMAX Pro Laser SystemCandela CorporationPDZ2024-09-24
07898961835013ETHEREA-MXVYDENCE MEDICALPDZ2024-05-27
07898961835037LongPulseVYDENCE MEDICALPDZ2024-05-27
07898961835204ZYE YAGVYDENCE MEDICALPDZ2024-05-27
07898961835211ZYE ALXVYDENCE MEDICALPDZ2024-05-27
078989618352425-15/ltVYDENCE MEDICALPDZ2024-05-27
00817495023564GMAX Pro Laser SystemCandela CorporationPDZ2022-12-16
00854103007059LightForce EXPiLITECURE LLCPDZ2017-07-24
00854103007035LightForce EXPLITECURE LLCPDZ2017-02-07
00858985006056LunulaERCHONIA CORPORATION, LLCPDZ2016-09-24
00816722021205Genesis PlusCUTERA, INC.PDZ2016-09-23
00816722023209Genesis Plus 1 mm Spot Size AdapterCUTERA, INC.PDZ2016-09-23
03830054230170Fotona XP FocusFOTONA d.o.o.PDZ2016-09-19
03830054230224Fotona XP FocusFOTONA d.o.o.PDZ2016-09-19
03830054230231Fotona XP-2 FocusFOTONA d.o.o.PDZ2016-09-19
03830054230095Lightwalker DTFOTONA d.o.o.PDZ2016-09-19
03830054230194Lightwalker ATFOTONA d.o.o.PDZ2016-09-19
03830054230293Lightwalker ST-EFOTONA d.o.o.PDZ2016-09-19
03830054230491Lightwalker DT STANDFOTONA d.o.o.PDZ2016-09-19
03830054230590Lightwalker ST-E STANDFOTONA d.o.o.PDZ2016-09-19
03830054230798Lightwalker DT ADVANCEDFOTONA d.o.o.PDZ2016-09-19
03830054230897Lightwalker ST-E ADVANCEDFOTONA d.o.o.PDZ2016-09-19
08033945934347Hyperblue plusQUANTA SYSTEM SPAPDZ2016-08-18