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510(k) Data Aggregation

    K Number
    K191121
    Device Name
    Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens
    Manufacturer
    Date Cleared
    2019-09-06

    (133 days)

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

    Lentechs, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Apioc, sphere/aspheric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The Apioc A, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters. The Apioc P, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myperopia) and presbyopia in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractism not exceeding 0.75 diopters and are presbyopic requiring add power of up to +4.00 diopters. The Apioc AP, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 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 or hydrogen peroxide disinfection systems.
    Device Description
    The Apioc , Apioc P, Apioc A, and Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lenses are designed with a lenticular zone for attachment to the upper eyelid. The contact lenses are fabricated from (efrofilcon A), which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (efrofilcon A) is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The material consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN). In the Apioc, Apioc P, Apioc A, and Apioc AP Contact Lens with UV Blocker and center thickness of 0.18mm. a Benzophenone UV absorbing monomer is used to block UV radiation. The UV blocking for lenses averages > 98% in the UVB range of 280nm - 315nm and >70% in the UVA range of 316 -380nm. The Apioc, Apioc P, Apioc A, and Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lenses will be manufactured in the sphere, aspheric, toric, multifocal, and multifocal toric design configurations.
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