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Found 8 results
510(k) Data Aggregation
K Number
K151562Device Name
Resultz Lice & Egg Removal Kit
Manufacturer
Piedmont Pharmaceuticals, LLC
Date Cleared
2017-05-08
(698 days)
Product Code
LJL
Regulation Number
880.5960Why 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
K163401Device Name
Nix Ultra Lice Treatment Kit
Manufacturer
MEDTECH PRODUCTS INC.
Date Cleared
2017-03-21
(106 days)
Product Code
LJL
Regulation Number
880.5960Why 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
K093144Device Name
LOUSEBUSTER
Manufacturer
LARADA SCIENCES
Date Cleared
2009-12-16
(72 days)
Product Code
LJL
Regulation Number
880.5960Why 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
K083206Device Name
LOUSEBUSTER
Manufacturer
LARADA SCIENCES
Date Cleared
2009-03-10
(130 days)
Product Code
LJL
Regulation Number
880.5960Why 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
K991958Device Name
KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
Manufacturer
KIEL LABORATORIES, INC.
Date Cleared
1999-08-13
(64 days)
Product Code
LJL
Regulation Number
880.5960Why 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
K981147Device Name
CLEAR (TM) LICE EGG REMOVER SYSTEM
Manufacturer
CARE TECHNOLOGIES, INC.
Date Cleared
1998-06-09
(71 days)
Product Code
LJL
Regulation Number
880.5960Why 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
K981250Device Name
LICEMEISTER COMB
Manufacturer
NATIONAL PEDICULOSIS ASSOC.
Date Cleared
1998-05-28
(52 days)
Product Code
LJL
Regulation Number
880.5960Why 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
K981037Device Name
CLEAR (TM) SPECIAL NIT COMB
Manufacturer
CARE TECHNOLOGIES, INC.
Date Cleared
1998-05-22
(64 days)
Product Code
LJL
Regulation Number
880.5960Why 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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