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510(k) Data Aggregation

    K Number
    K150419
    Device Name
    miraDry System MD4000
    Manufacturer
    MIRAMAR LABS, INC.
    Date Cleared
    2015-06-19

    (121 days)

    Product Code
    OUB, MWY, NEY
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    OUB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The miraDry System MD4000 is indicated for use in the treatment of primary axillary hyperhidrosis plus unwanted underarm hair removal, and permanent reduction of underarm hair of all colors for Fitzpatrick skin types I - IV. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs reasured at 6. 9 and 12 months after the completion of a treatment regime.
    Device Description
    The miraDry System MD4000 is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the axillary sweat glands and hair bulbs reside using a surface contact applicator. The miraDry System MD4000 consists of: the MD4000-MC Console; the MD4000-HP miraDry Handpiece; and a disposable, sterile MD4000-BT miraDry bioTip that snaps onto the Handpiece to provide a sterile protective cover. As described in K131162, the miraDry System MD4000 also includes Class I components/accessories. The MD4000-TS template system is a required component for the miraDry treatment as well as the MD4000-PK priming kit. The MD4000-PK priming kit is required when the system is initially set up at a user facility. Optional accessories include an armrest and disposable ice packs. The MD4000-MC Console is a software-driven device which contains circuit boards, a microwave generator, integrated vacuum and cooling systems, and an integrated touch-screen user interface. The non-invasive miraDry Handpiece is specifically designed to deliver microwave energy to the skin at specified frequency and power levels. The proximal end of the Handpiece has a cable bundle and a console connector that supplies the energy and cooling to the Handpiece. The distal end has a sterile, disposable barrier, the miraDry bioTip, which contacts the patient.
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    K Number
    K131162
    Device Name
    MIRADRY SYSTEM
    Manufacturer
    MIRAMAR LABS, INC.
    Date Cleared
    2013-10-25

    (184 days)

    Product Code
    OUB, NEY
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    OUB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The miraDry System is indicated for use in the treatment of primary axillary hyperhidrosis. Note: The miraDry System is not indicated for use in the treatment of hyperhidrosis related to other body areas or generalized hyperhidrosis.
    Device Description
    The miraDry System is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the axillary sweat glands reside using a surface contact applicator. The miraDry System consists of: the MD4000-MC Console; the MD4000-HP miraDry Handpiece; and a disposable, sterile MD4000-BT miraDry bioTip that snaps onto the Handpiece to provide a sterile protective cover. As described in K103014, the miraDry System also includes Class I components/accessories. The MD4000-TS template system is a reguired component for the miraDry treatment as well as the MD4000-PK priming kit. The MD4000-PK priming kit is required when the system is initially set up at a user facility. Optional accessories include an Armrest and disposable ice packs. The MD4000-MC Console is a software-driven device which contains circuit boards, a microwave generator, integrated vacuum and cooling systems, and an integrated touch-screen user interface. The non-invasive miraDry Handpiece is specifically designed to deliver microwave energy to the skin at specified frequency and power levels. The proximal end of the Handpiece has a cable bundle and a console connector that supplies the energy and cooling to the Handpiece. The distal end has a sterile, disposable barrier, the miraDry bioTip, which contacts the patient. The technological characteristics and the principles of operation for the MD4000 miraDry System are the same as the predicate miraDry System.
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    K Number
    K103014
    Device Name
    MIRADRY SYSTEM
    Manufacturer
    MIRAMAR LABS, INC.
    Date Cleared
    2011-01-28

    (107 days)

    Product Code
    OUB, NEY
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    OUB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The miraDry System is indicated for use in the treatment of primary axillary hyperhidrosis. Note: The miraDry System is not indicated for treating hyperhidrosis related to other body areas or generalized hyperhidrosis.
    Device Description
    The miraDry System is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the sweat glands reside using a surface contact applicator. The miraDry System consists of: the DTS3000 Console: the miraDry Handpiece; and a disposable, sterile miraDry bioTip that snaps onto the Handpiece to provide a sterile protective cover. The DTS3000 Console is a software-driven device which contains circuit boards, a microwave generator, integrated vacuum and cooling systems, and an integrated touch-screen user interface. The non-invasive miraDry Handpiece is specifically designed to deliver microwave energy to the skin at specified frequency and power levels. The proximal end of the Handpiece has a cable bundle and console connector that supplies the energy and cooling to the Handpiece. The distal end has a sterile, disposable barrier, the miraDry bioTip, that contacts the patient.
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