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510(k) Data Aggregation

    K Number
    K151562
    Device Name
    Resultz Lice & Egg Removal Kit
    Manufacturer
    Piedmont Pharmaceuticals, LLC
    Date Cleared
    2017-05-08

    (698 days)

    Product Code
    LJL
    Regulation Number
    880.5960
    Why did this record match?
    Product Code :

    LJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Resultz® Lice & Egg Removal Kit is intended to be used to remove head lice and their eggs from hair. The kit contains a fine-toothed nit comb and cosmetic based combing aid.
    Device Description
    The kit contains a fine-toothed nit comb and cosmetic based combing aid.
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    K Number
    K163401
    Device Name
    Nix Ultra Lice Treatment Kit
    Manufacturer
    MEDTECH PRODUCTS INC.
    Date Cleared
    2017-03-21

    (106 days)

    Product Code
    LJL
    Regulation Number
    880.5960
    Why did this record match?
    Product Code :

    LJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nix® Ultra Lice Treatment Kit is intended to kill and remove head lice and their eggs from adults and children two years of age or older.
    Device Description
    The Nix® Ultra Lice Treatment Kit consists of two components: Nix® Ultra Lice Killing Solution and Nix® Ultra Lice Removal Comb. The kit also includes an Instructions for Use Leaflet. Nix® Ultra Lice Killing Solution is a formulated device containing dimethicone and isoparaffin. The product kills lice and their eggs by physically coating the lice and clogging the spiracles through which they breathe and conduct water exchange; the solution also lubricates the hair to facilitate removal of dead lice and nits with the supplied comb. The Nix® Ultra Lice Treatment Kit is intended for over-the-counter use.
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    K Number
    K093144
    Device Name
    LOUSEBUSTER
    Manufacturer
    LARADA SCIENCES
    Date Cleared
    2009-12-16

    (72 days)

    Product Code
    LJL
    Regulation Number
    880.5960
    Why did this record match?
    Product Code :

    LJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LouseBuster™ is intended for use to kill or remove lice and lice eggs in the head hair of adults and children 4 years of age and older.
    Device Description
    The LouseBuster (LB) is a portable, electrically powered, reusable, device that can be used to direct controlled, heated airflow to kill Lice on the hair and scalp of patients with head lice infestations. The device consists of an applicator, a flexible delivery hose, and a base unit comprising heating and air movement elements with associated safety monitoring and temperature control circuitry. The mechanical and electrical components of the device are protected in a molded, non-metallic housing. A detachable delivery hose provides a pathway for channeling the flowing, heated air created in the base unit to the single-use, disposable applicator. The single-use applicator is attached to the hose by the user before initiating LB treatment. During treatments, the applicator is manually positioned by the user to systematically direct heated air to kill or remove lice present in the scalp and hair roots of an infested individual.
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    K Number
    K083206
    Device Name
    LOUSEBUSTER
    Manufacturer
    LARADA SCIENCES
    Date Cleared
    2009-03-10

    (130 days)

    Product Code
    LJL
    Regulation Number
    880.5960
    Why did this record match?
    Product Code :

    LJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LouseBuster™ is intended for use to kill or remove lice and lice eggs in the head hair of adults and children 4 years of age and older.
    Device Description
    The LouseBuster (LB) is a portable, electrically powered, reusable, prescription-use device that can be used to direct controlled, heated airflow to kill Lice on the hair and scalp of patients with head lice infestations. The device consists of an applicator, a flexible delivery hose, and a base unit comprising heating and air movement elements with associated safety monitoring and temperature control circuitry. The mechanical and electrical components of the device are protected in a molded, non-metallic housing. A detachable delivery hose provides a pathway for channeling the flowing, heated air created in the base unit to the single-use, disposable applicator. The single-use applicator is attached to the hose by the user before initiating LB treatment. During treatments, the applicator is manually positioned by the user to systematically direct heated air to kill or remove lice present in the scalp and hair roots of an infested individual.
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    K Number
    K991958
    Device Name
    KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
    Manufacturer
    KIEL LABORATORIES, INC.
    Date Cleared
    1999-08-13

    (64 days)

    Product Code
    LJL
    Regulation Number
    880.5960
    Why did this record match?
    Product Code :

    LJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    the removal of head lice and their eggs (nits) from hair
    Device Description
    The kit consists of two components, the combing pretreatment shampoo. The comb is stainless steel with the teeth set to 0.3 mm (300 micron) spacing and capable of removing nits which are greater than 0.3 mm when attached to the hair. The second element is a shampoo that contains no pesticides but does facilitate lice removal and allows for rinsing and combing the nits out of the hair.
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    K Number
    K981147
    Device Name
    CLEAR (TM) LICE EGG REMOVER SYSTEM
    Manufacturer
    CARE TECHNOLOGIES, INC.
    Date Cleared
    1998-06-09

    (71 days)

    Product Code
    LJL
    Regulation Number
    880.5960
    Why did this record match?
    Product Code :

    LJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To remove lice eggs from hair.
    Device Description
    The product is a system consisting of two components: (a) a glass reinforced nylon fine tooth nit comb; and (b) an enzyme gel cleansing agent intended to be used together with the comb to facilitate the combing out of lice eggs (nits) from the hair. The combing aid gel is a non-toxic water based vegetable derived enzyme composition. The product is substantially equivalent to other nit removal products, including the Innocomb Lice Comb (K822421) and the Innomed PD-1 Kit (K822574). The technological characteristics of the nit comb component are the same as other marketed products, including the predicate devices, which range from 100 to 200 microns of spacing between comb teeth (0.1 to 0.2 mm). Spacing between the teeth of the comb component is 0.2 mm. The minimum width of a lice nit adhering to a human hair is approximately 300 microns (0.3 mm).
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    K Number
    K981250
    Device Name
    LICEMEISTER COMB
    Manufacturer
    NATIONAL PEDICULOSIS ASSOC.
    Date Cleared
    1998-05-28

    (52 days)

    Product Code
    LJL
    Regulation Number
    880.5960
    Why did this record match?
    Product Code :

    LJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    cleening DETECTION THEIR E of LICE
    Device Description
    Not Found
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    K Number
    K981037
    Device Name
    CLEAR (TM) SPECIAL NIT COMB
    Manufacturer
    CARE TECHNOLOGIES, INC.
    Date Cleared
    1998-05-22

    (64 days)

    Product Code
    LJL
    Regulation Number
    880.5960
    Why did this record match?
    Product Code :

    LJL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For lice egg detection and removal
    Device Description
    The product is a nit comb intended for use in detecting and removing lice eggs from the hair. It is constructed of closely spaced stainless steel teeth imbedded in a high density polyethylene handle. The points and edges of the teeth are rounded so as not to cut or damage hair or scalp. The comb can be cleaned with soap and water after use and can withstand boiling water disinfection. The product is substantially equivalent to other nit removal combs, including the Innocomb Lice Comb (K822421) and Innomed PD-1 Kit (K822574). The technological characteristics of the Clear Special Nit Comb are the same as other marketed nit combs, including the predicate devices, which range from 100 to 200 microns of spacing between comb teeth. The minimum width of a lice nit adhering to a human hair is approximately 300 microns (0.3mm). The spacing between the teeth of the Clear Special Nit Comb is 200 microns (0.2mm).
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