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510(k) Data Aggregation

    K Number
    K243330
    Device Name
    LYMA Laser PRO
    Manufacturer
    LYMA Life Ltd.
    Date Cleared
    2025-02-21

    (120 days)

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

    LYMA Life Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LYMA Laser PRO is an Over-the-Counter (OTC) light based device intended for the use in treating face wrinkles.
    Device Description
    The LYMA Laser PRO is a compact, handheld laser device intended to provide low-level laser light therapy (LLLT) for the treatment of wrinkles. The LYMA Laser PRO system is composed of a handheld casing enclosing three low-level, 808nm laser diodes, and three red light-emitting diodes (LED). The device also includes one white LED that inform the user about device status during operation, and optical lenses that diffuse the laser light across a larger treatment window. The LYMA Laser PRO includes a rechargeable battery and is provided with a power cable.
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    K Number
    K210823
    Device Name
    LYMA Laser
    Manufacturer
    LYMA Life Ltd.
    Date Cleared
    2022-03-18

    (364 days)

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

    LYMA Life Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LYMA Laser is an Over the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.
    Device Description
    The LYMA Laser is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles. The LYMA Laser incorporates a near-infrared LED light source within the optimum Therapeutic Optical Window at 808 nm, optimized for Low Level Light Therapy, and a red LED light source at 620 nm. An optical lens that diffuses the light to produce narrowband, divergent distribution across an 8 cm² treatment area. The energy output of the 808 nm and 620 nm wavelengths is 62.5 mW/cm² which produces a beneficial treatment for full-face wrinkles.
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