BEUDAMED
    Product Code: QAI FDA class 2 21 CFR 878.4430

    Powered Microneedle Device

    General, Plastic Surgery

    The Powered Microneedle Device is a powered aesthetic device that uses one or more needles to mechanically puncture and injure skin tissue, used for aesthetic purposes such as skin rejuvenation and collagen induction therapy (microneedling). It is classified as a Class 2 device under regulation 878.4430, requiring 510(k) premarket notification, and falls within the General, Plastic Surgery (SU) medical specialty. The product code is QAI. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    26
    FEI Numbers
    57
    Registration Numbers
    57
    Unique Applicants
    18
    Years Active
    8

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    Basic Information

    Product Code
    QAI
    Device Class
    FDA class 2
    Regulation Number
    878.4430
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 26 510(k) clearances via K numbers.

    K Number Device Name
    K252591 Automatic Micro Needle System (CODE-X)
    K253002 SkinStylus SteriLock MicroSystem (MP1209SL)
    K252752 ellacor System with Micro-Coring Technology
    K253153 SER Pen Carain MicroSystem (MP1209SP)
    K243800 PRO Pen Microneedling System (6883)
    K243143 E-PEN (E-PEN)
    K243472 1NEED Pro
    K241790 XCELLARISPRO TWIST microneedling device
    K241355 SER Pen Carain MicroSystem (MP1209SP)
    K241400 SkinPen Precision Elite System
    K233709 Exceed Unlimited
    K230420 Dr. pen Microneedling System
    K231073 SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
    K221070 DP4 Microneedling device
    K221011 AI.ME System
    K222199 Collagen P.I.N. (Percutaneous Induction Needling)
    K220506 SkinPen Precision System
    K212558 MicroPen EVO
    K202517 Cytrellis Dermal Micro-Coring System
    K203144 MicroPen EVO
    K202243 SkinPen Precision System
    K200044 SkinStylus SteriLock MicroSystem
    K192138 Rejuvapen NXT
    K182407 Exceed Microneedling device
    K180778 Exceed Microneedling Device
    DEN160029 SkinPen Precision System

    FEI Numbers

    This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 57 registration numbers. Click on an entry to view related FDA registrations.