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

    6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION

    K Number: K862698 · Decision Aug 5, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    18
    Applicant Total
    54
    Review Days
    21

    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
    6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION
    K Number
    K862698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Cooper Lasersonics, Inc.
    Date Received
    July 15, 1986
    Decision Date
    August 5, 1986
    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 Cooper Lasersonics, Inc.

    K Number Device Name
    K880429 ILLUMINA 55 CO2 LASER SYSTEM
    K880427 ILLUMINA 40 CO2 LASER SYSTEM
    K880807 ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU
    K880428 ILLUMINA 25 CO2 LASER SYSTEM
    K880808 ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU
    K880809 ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU
    K880171 MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL
    K880170 MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
    K880173 MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
    K880172 MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.
    Search all 54 clearances from Cooper Lasersonics, Inc. →