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510(k) Data Aggregation

    K Number
    K222352
    Device Name
    Epildream HP 4000 MED
    Date Cleared
    2023-04-27

    (266 days)

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

    D.E.A Project S.r.1.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EPILDREAM HP 4000 MED is indicated for: use in aesthetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery. 760 nm wavelength laser is indicated for : Hair removal, permanent hair reduction* 808 nm wavelength laser is indicated for : Hair removal, permanent hair reduction* 1060 nm wavelength laser is indicated for: - · Treatment of pseudofolliculitis barbae (PFB) - · Hair removal, permanent hair reduction* *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. Use on all skin types (Fitzpatrick I-VI), including tanned skin. The handpiece which uses three wavelengths simultaneously is indicated for use in dermatology procedures requiring coagulation, and for the removal of benign vascular and vascular dependent lesions.
    Device Description
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