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510(k) Data Aggregation

    K Number
    K192138
    Device Name
    Rejuvapen NXT
    Manufacturer
    Refine USA LLC
    Date Cleared
    2020-04-09

    (245 days)

    Product Code
    QAI
    Regulation Number
    878.4430
    Why did this record match?
    Applicant Name (Manufacturer) :

    Refine USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rejuvapen NXT is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I-IV. The Rejuvapen NXT is intended for use on adults at least 22 years of age.
    Device Description
    The Rejuvapen is a handheld instrument that contains a Single Use micro needle cartridge containing 12 stainless steel microneedles in a circular arrangement with an adjustable microneedle depth of up to 2.5 mm. The needles create very small punctures in the epidermal and dermal layers of the skin. The device is powered by a medical grade wall plug-in supply. An adjustment is provided for a variable speed motor that controls the frequency of the puncture process with a
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