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510(k) Data Aggregation

    K Number
    K243143
    Device Name
    E-PEN (E-PEN)
    Manufacturer
    BOMTECH ELECTRONICS CO., LTD.
    Date Cleared
    2025-04-07

    (189 days)

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

    BOMTECH ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The E-PEN 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 E-PEN is a microneedling device that mechanically creates microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The E-PEN is comprised of a reusable pen body, a sterile, single use microneedling cartridge, and a power adapter. 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 condition of the skin being treated. Charging is accomplished by attaching the E-PEN pen body to the power adapter.
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    K Number
    K243097
    Device Name
    RM STAR EX with RMS Needle
    Manufacturer
    BOMTECH ELECTRONICS CO., LTD.
    Date Cleared
    2024-12-26

    (87 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOMTECH ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RM STAR EX with RMS Needle is intended for use in dermatologic procedures for electrocoagulation and hemostasis.
    Device Description
    The RM STAR EX with RMS Needle includes a system main device and a handpiece equitable with a bipolar electrode. The RF signal is generated from the main device which is then delivered to the handpiece and then to bipolar electrode. The RF signal is delivered to the target tissue using penetrating needle electrodes in the consumable tip. The bipolar electrode is placed in light contact with the epidermis while the handpiece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electrothermal reaction which is capable of coagulating the tissue. Using the consumable tip, RM STAR EX with RMS Needle creates heat within the target skin tissue via needle electrodes from the bipolar electrode.
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