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

    SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE

    K Number: K880071 · Decision Mar 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    9
    Applicant Total
    5
    Review Days
    71

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    Basic Information

    Device Name
    SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE
    K Number
    K880071
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Laserguide
    Date Received
    January 11, 1988
    Decision Date
    March 22, 1988
    Product Code
    FCS
    Advisory Committee
    Gastroenterology, Urology
    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
    FCS Light, Catheter, Fiberoptic, Glass, Ureteral

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    Other Clearances by Laserguide

    K Number Device Name
    K873892 SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE
    K875104 SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE
    K873664 LIGHT-SPOT FIBEROPTIC LASER HANDPIECE
    K873571 LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE