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510(k) Data Aggregation

    K Number
    K241790
    Device Name
    XCELLARISPRO TWIST microneedling device
    Manufacturer
    Dermaroller GmbH
    Date Cleared
    2025-03-06

    (258 days)

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

    Dermaroller GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XCELLARISPRO TWIST microneedling device and accessories is intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I. II, III and IV in adults aged 22 years or older and for treatment of wrinkles in Fitzpatrick skin types I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.
    Device Description
    The XCELLARISPRO TWIST is a microneedling device and intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainlesssteel needles. The XCELLARISPRO TWIST has 4 component parts and 2 consumables. Component parts: (1) handpiece, (2) control unit, (3) power supply and (4) foot switch. Consumables: (1) sterile, single-use needling module (Ethylene oxide sterilized) and (2) disposable barrier sleeves that cover the handpiece during each patient use.
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