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510(k) Data Aggregation

    K Number
    K120527
    Device Name
    ALPHA ORTHOPAEDICS AT2 SYSTEM
    Date Cleared
    2012-06-18

    (117 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALPHA ORTHOPAEDICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The AT2 System utilizes monopolar radiofrequency energy for coagulation and to induce tissue changes in dermatologic and general surgical procedures. It consists of a RF generator, cooling module, handpiece, and sterile disposable single-patient use treatment electrodes. It uses accessories including coupling fluid, return pad, coolant canister, and skin marking paper. The AT2 System applies to specific areas of the body radiofrequency energy while cooling the surface of the tissue in contact with the treatment electrode and uses dielectric as the method of applying radiofrequency via the treatment electrode. This submission adds treatment electrodes that have electrode patient contact surface area of 0.25cm² and 1.50cm².
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    K Number
    K094041
    Device Name
    ALPHA ORTHOPAEDICS AT3 SYSTEM
    Manufacturer
    Date Cleared
    2010-04-07

    (98 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALPHA ORTHOPAEDICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The radiofrequency-energy only delivery components of the Alpha Orthopaedics AT3 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis. The simultaneous application of radiofrequency energy and skin vibration by the Alpha Orthopaedics AT3 System is indicated for use in: - General surgical procedures for electrocoagulation and hemostasis . - . Relief of minor muscle aches and pain - . Relief of muscle spasms - Temporary improvement of local circulation (i.e., blood circulation) .
    Device Description
    The AT3™ System delivers RF energy while cooling tissue by conduction. Components and accessories include the handpiece with vibration, return pad, electronic footswitch (optional), cryogen canister, coupling fluid, skin marking paper, and treatment electrodes.
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    K Number
    K082956
    Device Name
    ALPHA ORTHOPAEDICS AT2 SYSTEM
    Manufacturer
    Date Cleared
    2008-12-18

    (76 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALPHA ORTHOPAEDICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AT2™ System is indicated for use in General Surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The AT2™ System consists of a RF generator and accessories, including disposable treatment electrodes.
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