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

    MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER

    K Number: K082707 · Decision Oct 1, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    6
    Review Days
    15

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    Basic Information

    Device Name
    MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER
    K Number
    K082707
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medx Electronics, Inc.
    Date Received
    September 16, 2008
    Decision Date
    October 1, 2008
    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 Medx Electronics, Inc.

    K Number Device Name
    K050022 MEDX HOME
    K032231 MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER
    K024310 NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY
    K021985 MEDX LCS LASER SERIES
    K020017 MEDX 1000 SERIES