BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    OrthoPulse

    K Number: K143120 · Decision Jul 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    267

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    Basic Information

    Device Name
    OrthoPulse
    K Number
    K143120
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biolux Research , Ltd.
    Date Received
    October 30, 2014
    Decision Date
    July 24, 2015
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PLH), ordered by most recent decision date.

    OrthoPulse 2.0E (OPi2E-100)

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