BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ellacor System with Micro-Coring Technology

    K Number: K252752 · Decision Oct 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    62

    Basic Information

    Device Name
    ellacor System with Micro-Coring Technology
    K Number
    K252752
    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
    Cytrellis Biosystems, Inc.
    Date Received
    August 29, 2025
    Decision Date
    October 30, 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

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    Other Clearances by Cytrellis Biosystems, Inc.

    K Number Device Name
    K202517 Cytrellis Dermal Micro-Coring System