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510(k) Data Aggregation

    K Number
    K244022
    Device Name
    308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
    Manufacturer
    Boston Aesthetics INC
    Date Cleared
    2025-03-13

    (76 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Boston Aesthetics INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 308nm UV Phototherapy System is intended to be used for the treatment of psorrasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is used on intact skin only.
    Device Description
    The 308nm UV Phototherapy System is available in four models, UV-K , UV-Y and UV-Z. It is a portable medical device, which consists of LED light board, heat dissipation module, control circuit, drive circuit, battery (applicable to UV-X, UV-Z), and power adapter. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders, which can be used in hospital, clinics and households. The device is mainly composed of a host and a power adapter. The LED light board of the device host contains light emitting diodes (LEDs), which create narrowband UVB light centered at a wavelength 308nm(±2nm) for the purpose of phototherapy. They are intended to be use in localized phototherapeutic treatment of dermatologic conditions(excluding eyes), such as psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is for the partial treatment and is intended to be used on intact skin only. The materials of the parts of the 308nm UV Phototherapy System that come into contact with the human body are mainly: PC, ABS.
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    K Number
    K241832
    Device Name
    Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
    Manufacturer
    Boston Aesthetics Inc
    Date Cleared
    2025-02-13

    (233 days)

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

    Boston Aesthetics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unicorn+ RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The RF System is used for the relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.
    Device Description
    Unicorn+ RF System is consist of a host, a trolley, a footswitch, a power cord, three kinds of handpieces and matched electrodes.
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