BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    TFX-LT2000 Therapy Light

    K Number: K211265 · Decision Nov 17, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    570

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    Basic Information

    Device Name
    TFX-LT2000 Therapy Light
    K Number
    K211265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Toefx, Inc.
    Date Received
    April 26, 2021
    Decision Date
    November 17, 2022
    Product Code
    PDZ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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

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