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

    ND:YAG LASER UROLOGICAL SURGERY

    K Number: K844459 · Decision Jan 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    24
    Review Days
    62

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    Basic Information

    Device Name
    ND:YAG LASER UROLOGICAL SURGERY
    K Number
    K844459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Endo Lase, Inc.
    Date Received
    November 15, 1984
    Decision Date
    January 16, 1985
    Product Code
    LNK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LNK Laser For Gastro-Urology Use

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    Other Clearances by Endo Lase, Inc.

    K Number Device Name
    K853900 ENDO-LASE CD40 FOR NEUROSURGERY
    K853878 ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY
    K855093 MEDILAS 2 ND:YAG LASER SURGERY SYSTEM
    K853903 ENDO-LASE CD40 CO2 FOR GYNECOLOGY
    K853876 ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY
    K853877 ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY
    K853901 ENDO-LASE CD 40 FOR DERMATOLOGY
    K853580 MEDILAS 2
    K860152 MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY
    K853902 ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY
    Search all 24 clearances from Endo Lase, Inc. →