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

    SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING

    K Number: K871515 · Decision Jul 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    7
    Review Days
    80

    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
    SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING
    K Number
    K871515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medical Energy, Inc.
    Date Received
    April 20, 1987
    Decision Date
    July 9, 1987
    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

    ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.

    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
    View all

    Other Clearances by Medical Energy, Inc.

    K Number Device Name
    K041419 LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM
    K871512 SL-100 ND:YAG LASER FOR GYNECOLOGY USE
    K871511 SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
    K871513 SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI
    K871514 SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID
    K871516 SL-100 ND:YAG LASER FOR UROLOGIC SURGERY