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

    PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10

    K Number: K031023 · Decision Jun 27, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    19
    Review Days
    88

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    Basic Information

    Device Name
    PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
    K Number
    K031023
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Peregrine Surgical , Ltd.
    Date Received
    March 31, 2003
    Decision Date
    June 27, 2003
    Product Code
    HQF
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQF Laser, Ophthalmic

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