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    K Number
    K152332
    Device Name
    Perfectio LED infrared device
    Manufacturer
    OMM IMPORTS INC DBA ZERO GRAVITY
    Date Cleared
    2016-02-25

    (191 days)

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

    OMM IMPORTS INC DBA ZERO GRAVITY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Perfectio LED infrared device 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.
    Device Description
    Perfectio LED infrared device is a battery operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nm emitting optical power in a uniform distribution with no hot spots. The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C. charging adapter. It is a hand held light emitting diode (LED) device for the treatment of periorbital wrinkles designed for home-use.
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