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

    NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY

    K Number: K024310 · Decision Mar 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    53
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY
    K Number
    K024310
    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
    December 24, 2002
    Decision Date
    March 24, 2003
    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.

    K Number Device Name
    K082707 MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER
    K050022 MEDX HOME
    K032231 MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER
    K021985 MEDX LCS LASER SERIES
    K020017 MEDX 1000 SERIES