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510(k) Data Aggregation

    K Number
    K231948
    Device Name
    MEDIYAG
    Manufacturer
    Medicreations LLC
    Date Cleared
    2024-10-09

    (467 days)

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

    Medicreations LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MediYag is indicated for: 532nm wavelength: treatment of benign pigmented lesions (Lentigines, Birthmark: Cafe-Au-Lait). 1064nm wavelength: treatment of acne scars, benign pigmented lesions (Nevus of Ota), and removal of dark ink tattoos (black, blue).
    Device Description
    The MediYag is a laser system which delivers a laser at a wavelength of 1064nm or 532nm. Component Name | Function ---|--- Main Unit | Main human-machine interface Articulated Arm | Articulated arm for holding of Treatment Probe Treatment Probe | Laser Delivery Foot Pedal | Control light output
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    K Number
    K231950
    Device Name
    MEDIDIODE
    Manufacturer
    Medicreations LLC
    Date Cleared
    2024-08-09

    (406 days)

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

    Medicreations LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MediDiode is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hair regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
    Device Description
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