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510(k) Data Aggregation

    K Number
    K153718
    Device Name
    Spirit Hair Removal laser Family
    Manufacturer
    ACTIVE OPTICAL SYSTEMS , LTD.
    Date Cleared
    2016-02-12

    (46 days)

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

    ACTIVE OPTICAL SYSTEMS , LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirit Hair Removal laser Family intended for dermatological use. The devices are specifically indicated for hair removal, permanent hair reduction by using selective laser energy. The Spirit Hair Removal laser Family is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent reduction in hair regrowth is defined as the longterm, 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 Spirit Hair Removal laser Family has two models of the same device (916, & 918) and several trade names. The devices apply photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a 810nm laser diode to the target tissue by a Treatment Handpiece that is in contact with the skin. The 918 and 916 models have fully identical HW. The difference in the optical output power (6 -90J/cm² for the 918 model and 4.5 to 10J/cm² for the 916 model) is preset. For the hair removal treatment, the devices utilized laser energy at the spectrum of 810nm (IR) which is absorbed by the Melanin which is located in the hair follicles. Once the energy is absorbed, it is turned into heat. The heat coagulates the hair follicles and removes the unwanted hair. The Spirit Hair Removal laser Family was designed to comply with international standards and is constructed from metal, plastic a diode laser and other electronic components.
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