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510(k) Data Aggregation

    K Number
    K203144
    Device Name
    MicroPen EVO
    Manufacturer
    Eclipse MedCorp, LLC
    Date Cleared
    2021-05-25

    (216 days)

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

    Eclipse MedCorp, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eclipse MicroPen EVO is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults 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 and dermal layers of the skin by means of micro-needles in a reciprocating cartidge head. The MicroPen EVO is comprised of a reusable pen body, a sterile, single use microneedling cartridge, a rechargeable battery pack, a battery charger with power supply, and a disposible MicroSleeve sheath. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending on the skin being treated. Charging is accomplished by placing the MicroPen EVO pen body or the battery pack on the Charger base.
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    K Number
    K200017
    Device Name
    Eclipse DermaFlex Cannula
    Manufacturer
    Eclipse MedCorp, LLC
    Date Cleared
    2020-11-05

    (307 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eclipse MedCorp, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eclipse DermaFlex Cannula is intended to inject fluids intradermally.
    Device Description
    The Eclipse DermaFlex Cannula is provided as a single-use, sterile device. It is comprised of a needle. hub and cap. This device comes in a variety of needle gauges and lengths. The Eclipse DermaFlex Cannula offers AN type and B Type. The AN type is a hypodermic single lumen needle intended to prepare the site for injection. The tip of this pilot needle is sharpened at one end, while the other end is joined to a hub. The B type has a metal tube with the tip, which is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end, the device is joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or secondary medication sets to prepare and administer fluids/ medications/ drugs to a patient.
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