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510(k) Data Aggregation

    K Number
    K161981
    Device Name
    Olive Plus
    Manufacturer
    Date Cleared
    2016-10-14

    (87 days)

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

    AMA NETWORK INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Olive Plus Diode Laser device is intended for use in dermatologic and general surgical procedures for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI) including tanned skin Skin Permanent hair reduction is defined as the long term, stable reduction in the number of hairs re-growing when measured at 6,9,and 12 months after the completion of a treatment regime.
    Device Description
    The Olive Plus Diode Laser system is a surgical device intended for use to remove or/and reduce un-wanted hair in Dermatologic and General Surgical procedure, emitting 810nm diode laser to the treatment area using Hand Pieces and foot switch. The laser beam penetrates through epidermis into dermis and absorbed by melanin in hair and hair follicle, producing laser photo thermal effect; conducting the energy from hair section to hair root, rising temperature of melanin and decomposing it, thus reaching effect of hair removal. During the treatment, the cooling system will operated to reduce the temperature of treatment area. Laser specification and other system features are controlled by LCD screen This device consists of Power supply system, Central Control System, Cooling System, Laser Delivery system and safety features. Hand piece tips are made by ABS plastic which are widely used in medical field.
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