BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TFX-LT2000 Therapy Light

    DI: 00086001245602 · Model: TFX-LT2000 · ToeFX Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    TFX-LT2000 Therapy Light
    Primary DI
    00086001245602
    Version / Model
    TFX-LT2000
    Company Name
    ToeFX Inc
    Labeler DUNS
    202099070
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-11-15
    Public Version
    1
    Public Version Date
    2024-11-25
    Public Version Status
    New
    Public Device Record Key
    75a008d8-92db-4712-b67f-a9492f269e31

    Device Description

    Light therapy device for onychomycosis

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

    GMDN Terms

    Code Name
    60388 Nail laser phototherapy unit

    Identifiers

    Type ID
    Primary 00086001245602