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510(k) Data Aggregation

    K Number
    K250125
    Device Name
    LMNT O2
    Manufacturer
    Date Cleared
    2025-03-24

    (66 days)

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

    XPLR Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LMNT O2 is an over-the-counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. In addition, LMNT O2 indicated to emit energy in the blue region of the spectrum for use in dermatology for the treatment of mild to moderate acne.
    Device Description
    LMNT O2 is a hand held device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±15nm, 830 ±15nm distribution with no hot spots for the treatment of periorbital wrinkles. The device also uses blue LED, at wavelength of 415 ±15nm emitting optical power in a uniform distribution with no hot spots for the treatment of acne.Designed for home-use.
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