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510(k) Data Aggregation

    K Number
    K253153

    Validate with FDA (Live)

    Device Name
    SER Pen Carain MicroSystem (MP1209SP)
    Manufacturer
    Su-Ko Technologies LLC
    Date Cleared
    2025-10-29

    (33 days)

    Product Code
    QAI
    Regulation Number
    878.4430
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K241355
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.

    Device Description

    The SER Pen Carain MicroSystem is a handheld powered microneedling device consisting of a rechargeable motorized handpiece and disposable, single-use needle cartridges (12-pin and 36-pin). Microneedles are made of surgical-grade stainless steel (304) and are gamma sterilized.

    Design modifications include:

    • Addition of a powered 7-speed control head (6,200–9,000 RPM) with direct corded power option.
    • Modified disposable cartridge (Model T2.0), shortened by 7 mm, with protective cap and compensatory spring.
    AI/ML Overview

    N/A

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