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510(k) Data Aggregation

    K Number
    K241400
    Device Name
    SkinPen Precision Elite System
    Manufacturer
    Crown Aesthetics
    Date Cleared
    2024-08-29

    (104 days)

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

    Crown Aesthetics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SkinPen® Precision Elite system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 vears and older.
    Device Description
    The SkinPen® Precision Elite System consists of a microneedling pen handpiece (SkinPen® Precision Elite) and a sterile needle cartridge (SkinPen® Precision Elite Cartridge). The accessories are a charging base with power adaptor and a BioSheath to cover the handpiece.
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    K Number
    K220506
    Device Name
    SkinPen Precision System
    Manufacturer
    Crown Aesthetics
    Date Cleared
    2022-03-07

    (13 days)

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

    Crown Aesthetics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.
    Device Description
    The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen® Precision) and a sterile needle cartridge (SkinPen® Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen® Precision System treatment kit is provided separately and contains the following: SkinPen® Precision Cartridge: sterile, disposable needle cartridge. Not to be resterilized or reused. (K202243, Class 2, Regulation 878.4430, Product Code: QAI.); Lift HG: hydrogel wound dressing (without drugs and/or biologics), to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure. (Class I, 510(k) Exempt, Regulation 878.4022, Product code: NAE.); SkinPen® BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen® Precision.; Sani-Cloth AF3: Sanitizing cloth available for purchase along with device to sanitize between uses.
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    K Number
    K202243
    Device Name
    SkinPen Precision System
    Manufacturer
    Crown Aesthetics
    Date Cleared
    2021-04-02

    (235 days)

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

    Crown Aesthetics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.
    Device Description
    The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen® Precision) and a sterile needle cartridge (SkinPen® Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen® Precision System treatment kit is provided separately and contains the following: SkinPen® Precision Cartridge: sterile, disposable needle cartridge. Not to be resterilized or reused. Lift HG: hydrogel wound dressing (without drugs and/or biologics), to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure. SkinPen® BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen® Precision.
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