BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    E-PEN (E-PEN)

    K Number: K243143 · Decision Apr 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    189

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    E-PEN (E-PEN)
    K Number
    K243143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4430
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bomtech Electronics Co., Ltd.
    Date Received
    September 30, 2024
    Decision Date
    April 7, 2025
    Product Code
    QAI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QAI Powered Microneedle Device

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QAI), ordered by most recent decision date.

    Automatic Micro Needle System (CODE-X)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SkinStylus SteriLock MicroSystem (MP1209SL)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ellacor System with Micro-Coring Technology

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SER Pen Carain MicroSystem (MP1209SP)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PRO Pen Microneedling System (6883)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    1NEED Pro

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Bomtech Electronics Co., Ltd.

    K Number Device Name
    K243097 RM STAR EX with RMS Needle