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

    Q-CLEAR

    K Number: K110370 · Decision Sep 15, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    18
    Applicant Total
    7
    Review Days
    219

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    Basic Information

    Device Name
    Q-CLEAR
    K Number
    K110370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Light Age, Inc.
    Date Received
    February 8, 2011
    Decision Date
    September 15, 2011
    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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    Other Clearances by Light Age, Inc.

    K Number Device Name
    K113115 EPICARE YAG
    K091625 EPICARE-DUO LASER SYSTEM
    K032991 LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
    K033259 LIGHT AGE Q-CLEAR LASER, MODEL 701-1101
    K983977 LIGHT AGE EPICARE ALEXANDRITE LASER
    K980131 ALEX TA2 ERASER