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510(k) Data Aggregation

    K Number
    K120756
    Device Name
    LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE
    Manufacturer
    THE LAGADO CORP.
    Date Cleared
    2013-05-13

    (426 days)

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

    THE LAGADO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters. The LSH (mangofilcon A) Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters and have near add requirements up to 3.25 Diopters. The LSH (mangofilcon A) Toric Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or non-aphakic persons with non diseased eyes in a spherical power range of +12.00 to -20.00 Diopters and a cylinder power range of -0.50 to 2.50 Diopters. The LSH (mangofilcon A) Toric-Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non-aphakic patients with non-diseased eyes in a spherical power range of +12.00 to -20.00 Diopters, a cylinder power range of -0.50 to 2.50 Diopters and an add requirement up to 3.25 Diopters. The lenses may be disinfected using chemical (not heat) disinfecting systems.
    Device Description
    The LSH (mangofilcon A) is available as a spherical, multifocal, toric, and toric-All LSH lenses are plasma treated in the dry state prior to initial multifocal lens. hydration. The lens material, (mangofilcon A), is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A (N.N-dimethyl acrylamide (NNDMA) polymer with 3-methacryloxy propyltris(trimethylsilyl)siloxane (TRIS)), trifluoroethyl methacrylate (TFEM), 2- hydroxyethyl methacrylate (HEMA), N-vinyl-2-pyrrolidone (NVP), cross-linked with ethyleneglycol dimethacrylate (EGDMA), and 49% water by weight. Mangofilcon A is available in clear (no tint) with or without a UV absorber to block a significant amount of the UV radiation occurring between 200 and 400 nm (UVA and UVB). The UV absorber is 2-(5-chloro-2H-benzotriazole-2-yl)-6-(1,1-dimethylethyl)-4- ethenyl phenol (UVAM). Mangofilcon A is available in Blue or Aqua visibility tints to assist with handling, and both colors are available with or without UV absorber. The Blue lenses are tinted using 1,4-Bis[4-(2-methacryloxyethy]) phenylamino]anthraquinone (21 CFR 73.3106), and the Aqua lenses are tinted using Phthalocyanine Green (21 CFR 73.312). The LSH (mangofilcon A) Sphere, Multifocal, Toric, and Toric-Multifocal Soft (hydrophilic) Lenses for Daily Wear are hemispheric flexible shells of the following dimensions. Diameter(s): Sphere 10.0 mm to 16.0 mm, Multifocal 14.0 mm to 16.0 mm, Toric Not Applicable (N/A), Toric-Multifocal 14.0 mm to 16.0 mm Center Thickness (Low Minus Lens): 0.07 mm dry Center Thickness (Plus Lens): Up to 0.50 mm Base Curve(s): 6.5 mm - 9.7 mm Powers: Sphere -20.00 D to +12.00 D, Multifocal -20.00 D to +12.00 D, Toric -20.00 D to +12.00 D, Toric-Multifocal -20.00 D to +12.00 D Cylinder Powers: Sphere N/A, Multifocal N/A, Toric -0.50 D to 2.50 D in steps of 0.25 D, Toric-Multifocal N/A Axes: Sphere N/A, Multifocal N/A, Toric 0° to 180°, Toric-Multifocal N/A Add Powers: Sphere N/A, Multifocal +1.00 D to +3.25 D in steps of 0.25 D, Toric N/A, Toric-Multifocal +1.00 D to +3.25 D in steps of 0.25 D The physical/optical properties of the lenses are: Oxygen Permeability (Dk) (35°C, Fatt Units): 49 Refractive Index: Dry - 1.470, Hydrated - 1.413 Specific Gravity: Dry - 1.112, Hydrated - 1.109 Linear Expansion Ratio: 1.26 Water Content: 49% Visible Light Transmittance: 96%T Plasma Treatment Required: Yes Shore D Hardness (in blank form): ≥83
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    K Number
    K130285
    Device Name
    PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
    Manufacturer
    THE LAGADO CORP.
    Date Cleared
    2013-04-03

    (57 days)

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

    THE LAGADO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Menicon Progent Large Diameter Contact Lens Case is only intended for use with the Menicon Progent Protein Remover for Rigid Gas Permeable (RGP) Contact Lenses. The Menicon Progent Large Diameter Contact Lens Case provides an alternative lens case to hold large diameter lenses (11 mm to 23 mm) during the Menicon Progent Protein Remover treatment. The case is not intended for disinfection (chemical, heat or peroxide). The case is not intended for lens storage.
    Device Description
    The Menicon Progent Large Diameter Contact Lens Case is a non-vented barrel style contact lens case. It consists of a clear polycarbonate (PC) cylinder with acrylonitrilebutadiene-styrene (ABS) copolymer non-vented screw cap and lens holder/basket. Each lens basket is molded with a letter, "L" or "R", for ease in proper lens identification. The left lens basket is also colored grey to assist patients who are not currently wearing their contact lenses. The lens case is capable of holding the 10 mL of Menicon Progent Protein Remover A/B mixed solution for effective protein removal.
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    K Number
    K102154
    Device Name
    TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
    Manufacturer
    THE LAGADO CORP.
    Date Cleared
    2011-01-21

    (175 days)

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

    THE LAGADO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TYRO™-97 (hofocon A) and ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable 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 only by using chemical disinfection
    Device Description
    The TYRO™ 97 (hofocon A) Rigid Gas Permeable lens material, hofocon A, is a polymer of trifluoroethyl methacrylate and silicone methacrylate, with no methyl methacrylate. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, [ 2-(2'-hydroxy-5'-methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color. The ONSI™-56 (onsifocon A) Rigid Gas Permeable lens material, onsifocon A,is a polymer of trifluoroethyl methacrylate polymer with tris (trimethylsiloxy) methacryloxypropylsilane 3trimethoxysilylpropylmethacrylate methacrylic acid 1,3-bis(3methacryloxypropyl)tetrakis(trimethylsiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone. The blue tinted onsifocon A lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, { 2-(2'-hydroxy-5'methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
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    K Number
    K052507
    Device Name
    TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR
    Manufacturer
    THE LAGADO CORP.
    Date Cleared
    2005-11-02

    (50 days)

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

    THE LAGADO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyoptic and which may exhibit corneal astigmatism. The lenses may be disinfected only by using chemical disinfection
    Device Description
    The TYRO ™ -97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses for Daily Wear are available in spherical, aspherical and toric designs in the clear untinted or blue, green and gray tinted varieties with and without UV-blocker. Each is a shell of the following dimensions. Spherical Contact Lens: Horizontal Lens Size: 6.5 mm to 11.50mm Base Curve: 6.50mm to 9.50mm Distance Powers: +12.00D to -20.00D Center Thickness: for low minus 0.05mm to 0.30mm for plus 0.10mm to 0.70mm Aspheric Lens Eccentricity -1.5 to 1.5 Oblate to prolate Peripheral Curves 0.1 to 1.0mm Toric Lens Axis 1 to 180 degrees in 1 degree step Cylinder power 0.50 to 4.00D Translating Bifocal Contact Lens: Horizontal Lens Size: 8.00mm to 10.50mm Base Curve: 6.50mm to 8.50mm Distance Power: +12.00D to -20.00D Add Power 1.00D to 4.00D The lens material, hofocon A, is a polymer of trifluoroethyl methacrylate and silicone methacrylate, with no methyl methacrylate. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and CI Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
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    K Number
    K033599
    Device Name
    ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
    Manufacturer
    THE LAGADO CORP.
    Date Cleared
    2004-09-16

    (307 days)

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

    THE LAGADO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONSIJ-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. The lenses may be disinfected only by using chemical disinfection
    Device Description
    The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses are available in spherical designs in the clear untinted or blue, green, gray, or blue-violet tinted varieties and blue tint with UV-blocker. Each is a shell of the following dimensions. Spherical Contact Lens: Horizontal Lens Size: 6.5 mm to 11.50mm Base Curve: 6.50mm to 9.50mm Distance Powers: +12.00D to -20.00D Center Thickness: for low minus 0.05mm to 0.30mm for plus 0.10mm to 0.70mm Aspheric Lens Eccentricity 0 to 1.5 Peripheral Curves 0.1 to 1.0mm Toric Lens Axis 1 to 180 degrees in 1 degree steps Cylinder power 0.50 to 4.00D Translating Bifocal Contact Lens: Horizontal Lens Size: 8.00mm to 10.50mm Base Curve: 6.50mm to 8.50mm Distance Power: +12.00D to -20.00D Add Power 1.00 to 4.00D The lens material, onsifocon A, is trifluoroethyl methacrylate polymer with tris (trimethylsiloxy)methacryloxypropylsilane 3-trimethoxysily|propylmethacrylate methacrylic acid 1,3-bis(3- methacryloxypropyl)tetrakis(trimethylsiloxy)disiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and CI Solvent Yellow 18; the blue-violet contain D&C Green No. 6 and D&C Violet No. 2; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
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