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510(k) Data Aggregation

    K Number
    K102857
    Device Name
    AHWON'S IPL SYSTEM
    Manufacturer
    AHWON MEDI INSTRUMENT CO., LTD
    Date Cleared
    2011-01-14

    (107 days)

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

    AHWON MEDI INSTRUMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ahwon RPL, R2PL system intended use for in Surgical, Asthetic and Cosmetic Application in Dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV.
    Device Description
    The Ahwon's RPL, R2P1 are IPL ( Intense pulsed light) system, using visible rays created by Xenon Lamp through Sapphire which are installed on Hand Piece, and composed Main Board, unit LCD monitor controlled by computer Hand pieces Cooling system. This device uses computer controlled Power supply and filter to generate light pulses of prescribed duration, intensity and spectral distribution. This device also equipped the Cooling systems to maintain both the Treatment head / Systems at appropriate and safe temperatures. The light pulses or emission spectra provide therapeutic indications relevant to specific wavelengths emitted from the system. This system has two hand pieces and each hand piece has 2 wavelengths to choose from. at the end of the Hand Piece, there is a sapphire filter and light is emitted when the button is pressed.
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