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

    SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS

    K Number: K871511 · Decision Jul 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    18
    Applicant Total
    7
    Review Days
    92

    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 PULMONARY OBSTRUCTIONS
    K Number
    K871511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Medical Energy, Inc.
    Date Received
    April 20, 1987
    Decision Date
    July 21, 1987
    Product Code
    LLO
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LLO Laser, Neodymium:Yag, Pulmonary Surgery

    Similar 510(k) Clearances

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

    SLT CLMD CONTACT LASER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SURGILASE YAG 100 FOR GYNECOLOGY USE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    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
    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
    K871515 SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING