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510(k) Data Aggregation

    K Number
    K130805
    Device Name
    MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
    Manufacturer
    MENICON CO. LTD.
    Date Cleared
    2013-07-03

    (100 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses.
    Device Description
    Menicon Unique pH Multi-Purpose Solution is a sterile, buffered aqueous solution. It contains hydroxypropyl guar, polyethylene glycol, poloxamine, boric acid, propylene glycol, and is preserve with polyquaternium-1 0.0011%, and edetate disodium 0.01%.
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    K Number
    K122273
    Device Name
    MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
    Manufacturer
    MENICON CO. LTD.
    Date Cleared
    2013-01-02

    (156 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
    Device Description
    Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (active ingredient, sodium hypochlorite) and Progent B (active ingredient, potassium bromide). Progent A and B are mixed in a Menicon SP Vial. Allow lenses to soak in the Progent solution mixture for 30 minutes. Soaking for longer than 30 minutes is not recommended. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eye care professional's directions (to a maximum of every 5 days).
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    K Number
    K102895
    Device Name
    ONE DAY FLAT PACK
    Manufacturer
    MENICON CO. LTD.
    Date Cleared
    2011-04-28

    (210 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.
    Device Description
    The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The One Day Flat Pack Daily Disposable Contact Lens packaging system is designed to reduce lens handling by always presenting the lens anterior side up upon opening, which ensures correct lens orientation for proper eye insertion. The approximately 1mm flat packaging system is easily opened and reinforces the single-use factor. The non-ionic lens material, (hioxifilcon A) is a random copolymer of 2- hydroxyethyl methacylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycero) Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifileon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a blue visibility-handling tint, color additive 'Reactive Blue # 19', 21 CFR part 73.3121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name. In the hydrated state, the lens conforms to the eve covering the corner and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
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    K Number
    K103561
    Device Name
    MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
    Manufacturer
    MENICON CO. LTD.
    Date Cleared
    2011-02-03

    (59 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Menicon Z™ (tisilfocon A) spherical, aspheric, prism ballast toric and prism ballast multifocal lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. Menicon Z™ (tisilfocon A) spherical, aspheric, non-prism ballast toric and non-prism ballast multifocal corneal lenses are indicated for extended wear (from 1 to 30 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare professional) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be prescribed in spherical and aspheric powers ranging from -25.00 D to +25.00 D for daily wear and -25.00 D to +8.00 D for up to 30 days extended wear. Toric lenses are designed to correct up to 5.00 D of astigmatism and multifocal lenses to provide up to +3.00 D of reading add power for up to 30 days extended wear. The lens may be disinfected using a chemical disinfection system only.
    Device Description
    The Menicon Z™ lens material, tisilfocon A is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents. The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (benzotriazol) is added.
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    K Number
    K082855
    Device Name
    MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
    Manufacturer
    MENICON CO. LTD.
    Date Cleared
    2010-03-09

    (526 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
    Device Description
    Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (sodium hypochlorite, sodium carbonate, sodium hydroxide, purified water) and Progent B (potassium bromide, sodium carbonate, purified water). Progent A and B are mixed in a Menicon SP Vial. Allow lenses to soak in the Progent solution mixture for 30 minute. Soaking for longer than 30 minutes is not recommended. P Progent Rinsing Solution (sterile purified water) is provided for rinsing the lenses and SP vial. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eve care professional's directions (to a maximum of every 5 days.
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    K Number
    K081443
    Device Name
    MENICON Z RIGID GAS PERMEABLE CONTACT LENS
    Manufacturer
    MENICON CO. LTD.
    Date Cleared
    2008-09-23

    (124 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not-aphakic persons with non-diseased eyes. The lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.
    Device Description
    The Menicon Z lens material, tisilfocon A is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents. The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (benzotriazol) is added. Lens designs for the management of irregular corneas include: 1) progressively flattening peripheral curves, 2) a reverse curve or series of reverse curves in the peripheral design, or 3) decentered optic zone and resulting peripheral curves, or 4) a combination of the first three systems.
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    K Number
    K020930
    Device Name
    MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
    Manufacturer
    MENICON CO. LTD.
    Date Cleared
    2002-05-02

    (41 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans, disinfects and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses. This product is for professional in-office use only.
    Device Description
    Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses consists of two solutions, Progent A and Progent B, which are mixed together when used. They are packaged separately in natural low density polyethylene (USP classification :VI) ampoules, type "Bottle Pack", containing 5.5 ml of solution, (5 ml being usable). Each package consists of 7 pairs of ampoules. Progent A contains sodium hypochlorite and sodium carbonate; Progent B contains potassium bromide and sodium carbonate. Rigid Gas Permeable Contact Lenses are placed into the lens holder cap of the cleaning vial (SP Vial). Progent A, then Progent B are poured into the case receptacle, then the lenses are soaked in the Progent mixture for 30 minutes.
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    K Number
    K002140
    Device Name
    MENICON PROGENT REMOVER
    Manufacturer
    MENICON CO. LTD.
    Date Cleared
    2000-10-10

    (85 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000233
    Device Name
    MENICON SF-P
    Manufacturer
    MENICON CO. LTD.
    Date Cleared
    2000-05-19

    (113 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962006
    Device Name
    MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
    Manufacturer
    MENICON CO. LTD.
    Date Cleared
    1996-10-09

    (140 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Menicon Z™ Rigid Gas Permeable Contact Lens for Daily Wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes who are myopic or hyperopic and have an astigmatism of up to 3.00 Diopters (D) that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.
    Device Description
    The Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens is a lathe-cut nonpolished firm contact lens with spherical front and back surfaces. The posterior curve is selected so as to properly fit an individual eye and the anterior curve selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The lens material, tisilfocon A, is a thermoset copolymer derived form fluoro-methacrylate and siloxanylstyrene, bound by crosslinking agents. The lens colors are light blue or clear. The lens is tinted light blue with color additive D & C Green No. 6. A UV absorber 2-(5-Chloro-2H- benzotriazol-2-y1)-6-(1,1dimethylethyl)-4-methylphenol is also added.
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