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510(k) Data Aggregation

    K Number
    K131712
    Device Name
    A-TONE IPL SYSTEM
    Date Cleared
    2014-05-30

    (353 days)

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

    YBK INVESTMENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A-tone systems are indicated for permanent hair reduction, and the treatment of benign vascular and pigmented lesions. 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
    Intense pulsed light system is a unit for general surgery and in dermatology using intense Pulsed Light system intended to cut, destroy, or remove tissue by light energy emitted by flash lamp. It is a light source with a wavelength range of approximately 530nm~1100nm. This equipment is composed of the main body and a hand piece which is an irradiation device, and, as an accessory part, protective goggles for protection of the worker. - Operation principle: This equipment is controlled by a micro-processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment and on and off of the equipment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board. Meanwhile, the control board connected to the touch screen is connected to the lamp of the hand piece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will radiate light, which will be outputted after being filtered to a certain wavelength (530nm~1100nm) by the two filters of the hand piece.
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