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

    Facet Aurora Reusable Lancet Base

    K Number: K232912 · Decision Jan 25, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    23
    Applicant Total
    7
    Review Days
    128

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    Basic Information

    Device Name
    Facet Aurora Reusable Lancet Base
    K Number
    K232912
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Facet Technologies, LLC
    Date Received
    September 19, 2023
    Decision Date
    January 25, 2024
    Product Code
    QRL
    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
    QRL Multiple Use Blood Lancet For Single Patient Use Only

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    Other Clearances by Facet Technologies, LLC

    K Number Device Name
    K223370 NeatNick Heel Safety Lancet
    K223099 Facet Manatee Reusable Lancing Base
    K222539 Facet Blood Lancets
    K221433 Facet 28G Universal Lancet
    K141749 CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT
    K140568 CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT