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

    MEDX LCS LASER SERIES

    K Number: K021985 · Decision Sep 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    53
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    MEDX LCS LASER SERIES
    K Number
    K021985
    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
    June 18, 2002
    Decision Date
    September 10, 2002
    Product Code
    NHN
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

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    Other Clearances by Medx Electronics, Inc.

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    K032231 MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER
    K024310 NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY
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