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

    LM 1000

    K Number: K854767 · Decision Jan 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    10
    Review Days
    58

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    Basic Information

    Device Name
    LM 1000
    K Number
    K854767
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Leisegang Medical, Inc.
    Date Received
    November 27, 1985
    Decision Date
    January 24, 1986
    Product Code
    GEH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEH Unit, Cryosurgical, Accessories

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    Other Clearances by Leisegang Medical, Inc.

    K Number Device Name
    K990043 SMOOTHLASE ALEXANDRITE LASER SYSTEM
    K940094 COLPOSCOPES AND ACCESSORIES
    K924134 LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS
    K920217 MAX-E-VAC
    K914201 LM- LAP 10 HIGH FLOW INSUFFLATOR
    K912789 LM-100/200LOW FLOW INSUFFLATOR
    K913135 LM-300TWIN
    K911212 LM-150HT LIGHT SOURCE
    K902313 LM-1Z ZOOM SCOPE