LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

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
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    E-PEN (E-PEN)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    This document is a 510(k) clearance letter for the E-pen microneedling device. It contains regulatory information and a summary of performance data. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical effectiveness or performance as an AI/software device. This type of information is typically found in clinical study reports, scientific publications, or more detailed regulatory submissions for AI-powered devices, which are not present in this 510(k) clearance letter for a microneedling device.

    The provided information focuses on:

    • Regulatory Classification: The device is a Class II microneedling device for aesthetic use (21 CFR 878.4430).
    • Intended Use: To improve the appearance of facial acne scars in adults aged 22 years and older.
    • Technical Specifications: Comparison with a predicate device (SkinPen Precision System, DEN160029) showing similar design, materials, and operating parameters (e.g., number of needles, needle gauge, penetration depth, speed).
    • Non-Clinical Performance Data: Biocompatibility, sterilization validation, sterility/shipping/shelf-life, EMC (Electromagnetic Compatibility), electrical safety, software validation (moderate level of concern), and bench testing (needle length, penetration depth, speed, prevention of re-use).

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving clinical effectiveness or AI performance based on this document. The document primarily demonstrates substantial equivalence to a predicate device based on technical and safety specifications, not a new clinical performance study against specific acceptance criteria for a health outcome based on AI.

    If this were a submission for an AI-powered device, the information requested (AI performance, ground truth, experts, etc.) would be crucial and would typically be provided in a different section or supplementary documentation.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1