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510(k) Data Aggregation

    K Number
    K213880
    Device Name
    Custom Stable Rigid Gas Permeable Scleral Contact Lens
    Manufacturer
    Valley Contax, Inc.
    Date Cleared
    2022-01-07

    (25 days)

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

    Valley Contax, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/ lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
    Device Description
    The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Custom Stable™ Rigid Gas Permeable (rofflufocon D, roflufocon E) Scleral Contact Lens is lathe cut from one of the following hydrophobic, fluorosilicone acrylate materials: roflufocon D (supplied by Contamac Ltd.) or roflufocon E (supplied by Contamac Ltd.).
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    K Number
    K202860
    Device Name
    Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)
    Manufacturer
    Valley Contax, Inc.
    Date Cleared
    2021-05-11

    (225 days)

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

    Valley Contax, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Valley Contax SV Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A ) is indicated for daily wear for the corrective error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system. The Valley Contax AFM Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A ) is indicated for daily wear for the corrective error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system. The Valley Contax VK Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A ) is indicated for daily wear for the corrective error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may also be prescribed in otherwise non-diseased eyes that require a gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
    Device Description
    The Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) for daily wear are made-to-order with spherical or aspheric front surfaces, or a prism-ballasted toric front surface. The Valley Contax AFM Gas Permeable Contact Lens is made-to-order in a range of multifocal strengths and options. The Valley Contax VK Gas Permeable Contact Lens is intended for the management of irregular cornea conditions and is made-to-order in spheric, prism-ballasted toric, and multifocal front surface options. The lenses are lathe cut from one of the following hydrophobic, fluorosilicone acrylate materials: roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A. The lenses are shipped "dry" in a polypropylene contact lens case.
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    K Number
    K170335
    Device Name
    Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens
    Manufacturer
    Valley Contax, Inc.
    Date Cleared
    2017-03-24

    (50 days)

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

    Valley Contax, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus. keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
    Device Description
    The Custom Stable "11 Rigid Gas Permeable Scleral Contact Lens for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Custom Stable "" Rigid Gas Permeable Scleral Contact Lens is lathe cut from one of the following hydrophobic, fluoro-silicone acrylate materials: - · roflufocon D (supplied by Contamac Ltd.) - · roflufocon E (supplied by Contamac Ltd.)
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