BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇦 Canada

    XE-LITE

    K Number: K954263 · Decision Oct 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    28
    Applicant Total
    9
    Review Days
    36

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    Basic Information

    Device Name
    XE-LITE
    K Number
    K954263
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Ophthalmic Technologies, Inc.
    Date Received
    September 12, 1995
    Decision Date
    October 18, 1995
    Product Code
    FTD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FTD Lamp, Surgical

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