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

    TANDA MAX

    K Number: K103415 · Decision Jan 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    42

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    Basic Information

    Device Name
    TANDA MAX
    K Number
    K103415
    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
    Pharos Life Corporation
    Date Received
    November 22, 2010
    Decision Date
    January 3, 2011
    Product Code
    ONE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    ONE Powered Light Based Non-Laser Surgical Instrument

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    Other Clearances by Pharos Life Corporation

    K Number Device Name
    K110735 TANDA MAX OTC SYSTEM
    K090008 TANDA RESTORE, MODEL PTSCS
    K080591 TANDA SKINCARE SYSTEM, MODEL: PTSCS
    K070185 TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001