BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    OrthoPulse 2.0E (OPi2E-100)

    K Number: K230905 · Decision Jun 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    70

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    Basic Information

    Device Name
    OrthoPulse 2.0E (OPi2E-100)
    K Number
    K230905
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biolux Technology GmbH
    Date Received
    March 31, 2023
    Decision Date
    June 9, 2023
    Product Code
    PLH
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PLH Orthodontic Led Accessory

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