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

    miraDry System

    K Number: K180396 · Decision Mar 15, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    64
    Applicant Total
    2
    Review Days
    30

    Basic Information

    Device Name
    miraDry System
    K Number
    K180396
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Miramar Labs, Inc.
    Date Received
    February 13, 2018
    Decision Date
    March 15, 2018
    Product Code
    NEY
    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
    NEY System, Ablation, Microwave And Accessories

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    Other Clearances by Miramar Labs, Inc.

    K Number Device Name
    K160141 miraDry System