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510(k) Data Aggregation

    K Number
    K172314
    Device Name
    Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
    Manufacturer
    Art Optical Contact Lens Inc
    Date Cleared
    2017-09-20

    (50 days)

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

    Art Optical Contact Lens Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is indicated for use for the management of irregular astigmatism, corneal degeneration or dystrophy caused by keratoconus, keratoglobus, pellucid marginal degeneration (PMD), post corneal trauma/scaring, post keratoplasty, post K-Pro, post RK, post LASIK, Salzmann's nodular degeneration. Cogan's dystrophy, granular corneal dystrophy, lattice corneal dystrophy or Reis-Bucklers dystrophy. The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is also indicated for therapeutic management of ocular surface disease from dry eye including ocular pemphigoid, Stevens-Johnson syndrome, symblepharon formation, graft vs host disease, persistent epithelial defect, exposure keratitis, neurotrophic keratopathy( herpes zoster, familial dysautonomia), Sjogern's syndrome, filamentary keratitis, limbal stem cell deficiency, atopy, ectodermal dysplasia. When prescribed for therapeutic use for irregular astigmatism or ocular surface diseases, the Ampleye Scleral RGP Lens may also provide correction of refractive error including myopia, presbyopia and regular astigmatism. Eye care 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 Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) 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 Ampleye Scleral RGP Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, or paflufocon D.
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