BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LITECURE THERAPY SYSTEM MODEL LTS-1500

    K Number: K123014 · Decision Mar 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    18
    Applicant Total
    7
    Review Days
    183

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    Basic Information

    Device Name
    LITECURE THERAPY SYSTEM MODEL LTS-1500
    K Number
    K123014
    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
    Litecure, LLC
    Date Received
    September 27, 2012
    Decision Date
    March 29, 2013
    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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