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510(k) Data Aggregation

    K Number
    K222800
    Device Name
    Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
    Date Cleared
    2022-11-07

    (52 days)

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

    Sanhe Laserconn Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Standard-A) is intended for hair removal permanent hair reduction on all 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
    Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is solution for fast hair removal with 810nm±10nm high power laser diodes. They are designed with TEC and sapphire cooling unit for skin contact. The laser beam is sublimated with a patented technology of beam shaping for a high efficiency for hair removal solution. This diode laser hair removal can be used for Fitzpatrick skin type I-VI. The pulse energy is up to 40J/cm².
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