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510(k) Data Aggregation

    K Number
    K182604
    Device Name
    New Era
    Date Cleared
    2018-11-14

    (54 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Step Up Skin Laser, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The New Era Laser is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
    Device Description
    The proposed device, New Era, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI); There is one model, FG 2000. The main components of proposed device shown as following: Handpiece, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch. The proposed system provides 36 working modes, which are six modes for men and six modes for women, the men or women mode includes Parameter one, two, three, four, five and six mode respectively for different preset parameter combination, and each particular parameter preset mode includes three submode as mode 1, mode 2 and mode 3. The difference for each mode is only the default parameter, but all parameters for each mode can be adjustable in the parameter range. The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black);
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