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510(k) Data Aggregation

    K Number
    K213690
    Device Name
    Eclipse Blood Collection Set
    Date Cleared
    2022-10-26

    (337 days)

    Product Code
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eclipse Medcorp LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Eclipse Blood Collection Set with holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
    Device Description
    The Eclipse Blood Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needle stick injury if manually activated after the blood draw. For blood collection, the set also includes a blood collection holder for connection to vacuum-based collection vials
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    K Number
    K212558
    Device Name
    MicroPen EVO
    Date Cleared
    2021-11-24

    (103 days)

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

    Eclipse Medcorp LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Eclipse MicroPen® EVO 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 Eclipse MicroPen EVO™ is a minimally invasive microneedling device that mechanically creates microscopic punctures in the epidermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The MicroPen EVO is comprised of a reusable pen body, a sterile, single use microneedlingcartridge, a rechargeable battery pack, and a battery charger with power supply. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetrationcan be adjusted by the user depending on the condition of the skin being treated. Charging is accomplished by placing the MicroPen EVO battery pack on the Charger base.
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