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510(k) Data Aggregation

    K Number
    K193399
    Device Name
    Miru 1day UpSide (midafilcon A)
    Manufacturer
    Menicon Co., Ltd.
    Date Cleared
    2020-06-17

    (194 days)

    Product Code
    LPL, MVN
    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 Miru 1day UpSide (midafilcon A) SPHERICAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myperopia) in aphakic and non-aphakic people with disease free eyes who may have 1.50 diopter (D) or less of astigmatism. The Miru 1day UpSide (midafilcon A) TORIC Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic people with disease free eyes with 3.00 diopter (D) or less of refractive astigmatism. The Miru 1day UpSide (midafilcon A) MULTIFOCAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia) and emmetropia with presbyopia in aphakic and non-aphakic people with disease free eyes who may require a reading addition of 3.00 diopter (D) or less and who may have 1.50 diopter (D) or less of astigmatism. The Miru 1day UpSide (midafilcon A) should only be worn once and then discarded at the end of each wearing period on a daily basis. The patient should start the next wearing period with fresh lenses should not be cleaned or disinfected and should be discarded after a single use.
    Device Description
    The Miru 1day UpSide (midafilcon A) is a hydrophilic contact lens which is available as a spherical, toric and multifocal lens. The lens is indicated for daily wear disposable single use. The non-ionic lens material (midafilcon A) is a random co-polymer containing polydimethyl siloxane macromonomer. It consists of 46% midafilcon A and 54% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibility handling tint. The lens contains a benzotriazole UV absorbing monomer which is used to block UV radiation. The transmittance characteristics for the lens (-3.00D) are less than 5% of UVB radiation and less than 50% of UVA radiation.
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    K Number
    K191872
    Device Name
    Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
    Manufacturer
    Menicon Co., Ltd.
    Date Cleared
    2020-03-02

    (234 days)

    Product Code
    LPN, MRC
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    Menicon Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.
    Device Description
    The Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution system consists of: Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case. The lens case consists of a transparent cup and a lens holder-lens case cap assembly with a neutralizer catalyst disk. Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case must always be used together. The preservative free, aqueous Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution contains: hydrogen peroxide 3%, phosphonic acid compound (stabilizer), citric acid, polyethylene glycol, sodium chloride, sodium hydroxide, and phosphate (buffer system).
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    K Number
    K180819
    Device Name
    One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
    Manufacturer
    Menicon Co., Ltd.
    Date Cleared
    2018-05-16

    (48 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
    One Day Flat Pack (hioxifilcon A) Spherical Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.00 diopter (D) or less of astigmatism that does not interfere with visual acuity. One Day Flat Pack (hioxifilcon A) Multifocal Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.00 D or less of astigmatism that does not interfere with visual acuity. One Day Flat Pack (hioxifilcon A) Spherical and Multifocal Lenses are intended to be worn once and then discarded at the end of each wearing period on a daily basis. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
    Device Description
    The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lenses are daily wear disposable soft contact lenses available as spherical and multifocal lens designs. 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 insertion. The non-ionic lens material. (hioxifilcon A) is a random copolymer of 2- hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 43 % hioxifilcon A and 57 % 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.
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    K Number
    K180004
    Device Name
    Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
    Manufacturer
    Menicon Co., Ltd.
    Date Cleared
    2018-02-22

    (51 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 Menicon ASRB (asmofilcon A) SPHERICAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.50 D or less of astigmatism. The Menicon ASRB (asmofilcon A) TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes with 3.00 D or less of refractive astigmatism. The Menicon ASRB (asmofilcon A) MULTIFOCAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.50 D or less of astigmatism. The Menicon ASRB (asmofilcon A) MULTIFOCAL TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia with astigmatism) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have up to approximately 3.00 D or less of refractive astigmatism. The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a frequent replacement lens. The lenses are intended to be worn on a daily wear basis with removal for cleaning and chemical disinfection (not heat) prior to reinsertion, as recommended by the eye care practitioner.
    Device Description
    The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a hydrophilic contact lens which is available as a spherical/aspherical, toric, multifocal and multifocal toric lens. This soft contact lens is indicated for daily wear frequent replacement. The non-ionic lens material (asmofilcon A) is a random co-polymer containing polydimethyl siloxane macromonomer. It consists of 60% asmofilcon A and 40% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibility handling tint, C.I. Reactive Blue 246. The hydrophilic material characteristics allow aqueous solutions to enter the lens. In its fully hydrated state, the lens is approximately 40% water by weight.
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    K Number
    K173136
    Device Name
    Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
    Manufacturer
    Menicon Co., Ltd.
    Date Cleared
    2017-11-16

    (48 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 Progent Vial. Menicon Rinse solution is used once the lens soaking cycle is complete. 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
    K133295
    Device Name
    QUALIS
    Manufacturer
    MENICON CO., LTD. NEW BUSINESS DIVISION
    Date Cleared
    2014-06-18

    (236 days)

    Product Code
    MQK
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON CO., LTD. NEW BUSINESS DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Qualis is intended for preparing motile human sperm for use in the treatment of infertile couples by intracytoplasmic sperm insertion (ICSI) fertilization.
    Device Description
    The Qualis is a sterile, disposable, plastic laboratory dish that contains four chambers connected through micro-channels and is designed to be used in conjunction with commercially available culture medium to selectively separate motile spermatozoa (sperm) for non-motile spermatozoa and cellular debris.
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