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

    ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY

    K Number: K875039 · Decision Apr 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    19
    Review Days
    128

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    Basic Information

    Device Name
    ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY
    K Number
    K875039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgilase, Inc.
    Date Received
    December 7, 1987
    Decision Date
    April 13, 1988
    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 Surgilase, Inc.

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    K905006 SURGILASE SL 150 SURGICAL LASER SYSTEM
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    K901211 SURGILASE SL50 SURGICAL LASER SYSTEM
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    K894471 SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY
    K894396 SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER
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