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510(k) Data Aggregation

    K Number
    K133546
    Device Name
    STARLITE-OM, LIGHT EFFECTS, THIBIANT
    Date Cleared
    2014-08-06

    (260 days)

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

    PS ADVANCED ENGINEERING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SL-8813 is an Over The Counter (OTC) handheld device intended for in the treatment of full face wrinkles
    Device Description
    SL-8813 is a handheld ergonomically designed ABS plastic housed device with a locking Medical Grade Stainless Steel retainer holding in place a Medical Grade USP Class polycarbonate lens from which high spectral purity LED light in 4 (four) specific wavelengths is emitted. By design the optical output has a high degree of homogenous light distribution. The output wavelengths are actuated via a simple on-off swipe button and are in the visible Red and the Infrared spectrum. SL8813 is powered by a built in (non user accessible) Lithium lon Battery which can be charged as required via a supplied UL listed AC/DC wall mounted unit. Treatment time for light outputs is controlled by the operator as per Treatment Protocols listed in User Documentation. Audible announcement is provided to the user for timing intervals of treatments and is so noted in User Documentation.
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    K Number
    K092460
    Device Name
    STAR-LITE -LM, MODEL SL8809
    Date Cleared
    2010-03-05

    (206 days)

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

    PS ADVANCED ENGINEERING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The StarLite-LM is a hand held device intended for Over The Counter patient usage to specifically reduce periorbital wrinkles. The target patient population would be identical to the population of the predicate device. StarLite-LM emits LED light energy in the Red and Infrared region.
    Device Description
    StarLite-LM is a handheld ergonomically designed ABS plastic housed device with a locking Medical Grade Stainless Steel retainer holding in place a Medical Grade polycarbonate lens from which high spectral purity LED light in 2 (two) specific wavelengths is emitted. By design the optical output has a high degree of homogenous light distribution. The output wavelengths are user selected via a simple pushbutton on alternate treatment days and are in the visible Red and the Infrared spectrum. StarLite-LM is powered by a built in Lithium lon Battery which can be charged as required via a supplied UL listed AC/DC wall mounted unit. Treatment time for both light outputs is controlled by the operator as per Treatment Protocols listed in User Documentation.
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