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

    TANDA RESTORE, MODEL PTSCS

    K Number: K090008 · Decision Oct 15, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    5
    Review Days
    286

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    Basic Information

    Device Name
    TANDA RESTORE, MODEL PTSCS
    K Number
    K090008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pharos Life Corporation
    Date Received
    January 2, 2009
    Decision Date
    October 15, 2009
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

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    Other Clearances by Pharos Life Corporation

    K Number Device Name
    K110735 TANDA MAX OTC SYSTEM
    K103415 TANDA MAX
    K080591 TANDA SKINCARE SYSTEM, MODEL: PTSCS
    K070185 TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001