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510(k) Data Aggregation

    K Number
    K090580
    Device Name
    THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES
    Manufacturer
    SOLTA MEDICAL, INC.
    Date Cleared
    2009-06-26

    (115 days)

    Product Code
    GEI,ISA
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K050397,K070092,K071872,K082622,K030876,K990445,K033942,K032088,K031046,K043402,K051710,K052778,K072849
    Why did this record match?
    Reference Devices :

    K050397, K070092, K071872, K082622, K030876, K990445

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The radiofrequency-energy only delivery components of the Thermage ThermaCool NXT System and Accessories are indicated for use in:

    • Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
    • Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids;
    • Non-invasive treatment of wrinkles and rhytids.

    The simultaneous application of radiofrequency energy and skin vibration by the Thermage ThermaCool NXT System and Accessories is indicated for use in:

    • Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
    • Non-invasive treatment of periorbital wrinkles and rhytids;
    • Non-invasive treatment of wrinkles and rhytids;
    • Temporary improvement in the appearance of cellulite;
    • Relief of minor muscle aches and pains;
    • Relief of muscle spasms:
    • Temporary improvement of local circulation (i.e., blood circulation).
    Device Description

    The Thermage ThermaCool NXT System delivers capacitively coupled radiofrequency energy while cooling tissue by conduction. Components and accessories include the Multiplex (16.0) Handpiece, Standard Handpiece, Treatment Tips, Return Pad, Electronic Footswich (optional), Cryogen Canister and Coupling fluid. The front panel of the ThermaCool NXT System is equipped with a receptacle to connect the Return Pad to each Handpiece Assembly, comprising the return path for electric current. The modified Standard Handpiece offers user-selectable vibration to provide concurrent mechanical manipulation of tissue in a manner similar to the predicate devices listed.

    AI/ML Overview

    This 510(k) submission (K090580) for the Thermage ThermaCool NXT System (TG-2B) provides a safety summary, but it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

    The document states in section F, "Summary": "By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool NXT System and Accessories is substantially equivalent to devices currently cleared for marketing in the United States." This indicates that the device was cleared based on substantial equivalence to predicate devices, rather than new clinical effectiveness or performance studies against specific acceptance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory classification, predicate devices, and intended use.

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