BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LAPEX 2000

    K Number: K034009 · Decision Jan 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    53
    Applicant Total
    7
    Review Days
    394

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    Basic Information

    Device Name
    LAPEX 2000
    K Number
    K034009
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meridian Co., Ltd.
    Date Received
    December 24, 2003
    Decision Date
    January 21, 2005
    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 Meridian Co., Ltd.

    K Number Device Name
    K102375 LUCIA
    K081962 LAPEX BCS
    K023238 MCPULSE
    K020360 ABR-2000
    K010897 MERIDIAN-PORTABLE
    K001347 MERIDIAN-II AND MERDIAN-PLUS