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

    Aspen Laser Systems Therapy Laser System

    K Number: K150138 · Decision May 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    106

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    Basic Information

    Device Name
    Aspen Laser Systems Therapy Laser System
    K Number
    K150138
    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
    Aspen Laser Systems, LLC
    Date Received
    January 22, 2015
    Decision Date
    May 8, 2015
    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 Aspen Laser Systems, LLC

    K Number Device Name
    K142078 VELASII THERAPY LASER SYSTEM