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

    MIRADRY SYSTEM

    K Number: K103014 · Decision Jan 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    107

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    Basic Information

    Device Name
    MIRADRY SYSTEM
    K Number
    K103014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Miramar Labs, Inc.
    Date Received
    October 13, 2010
    Decision Date
    January 28, 2011
    Product Code
    OUB
    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
    OUB Instrument For Treatment Of Hyperhidrosis

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    Other Clearances by Miramar Labs, Inc.

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    K131162 MIRADRY SYSTEM
    K082819 DERMATOLOGIC TREATMENT SYSTEM (DTS) G2