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

    ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.

    K Number: K874253 · Decision Jul 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    12
    Review Days
    266

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.
    K Number
    K874253
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Minnesota Laser Corp.
    Date Received
    October 20, 1987
    Decision Date
    July 12, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LNK), ordered by most recent decision date.

    TECHNOMED PULSOLITH 4000 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MDL-2000 LASERTRIPTER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Minnesota Laser Corp.

    K Number Device Name
    K874255 ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.
    K874254 ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS
    K854473 PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC
    K854468 PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC
    K854471 PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T
    K854472 PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG
    K854469 PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG
    K854470 PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI
    K852694 PORTALASE 200 CARBON SURGICAL LASER SYSTEM
    K852696 FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY
    Search all 12 clearances from Minnesota Laser Corp. →