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510(k) Data Aggregation

    K Number
    K172692
    Device Name
    Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
    Manufacturer
    Tangible Science LLC
    Date Cleared
    2017-12-13

    (98 days)

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

    Tangible Science LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. The Tangible Hydrogel with Tangible Polymer (etafilcon A) TORIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who may have 5.00 D or less of astigmatism. The Tangible Hydrogel with Tangible Polymer (etafilcon A) MULTIFOCAL Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 2.50 D of ADD power and may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.
    Device Description
    The Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available in an aspheric design and manufactured using the castmolding process. The lenses consist of 58% water and 42% etafilcon A. The lens material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which are cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lenses are available in a light blue tint ([Phthalocvaninato(2-)]copper) for visibility and handling. The lenses also contain a Benzotriazole ultraviolet (UV) absorbing monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range (280 to 315 nm), and less than 30% in the UVA range (316 to 380nm). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (etafilcon A) soft hydrophilic contact lens has an aspheric back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The lenses are supplied sterile in blister packages containing a buffered saline solution. Package labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.
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    K Number
    K171125
    Device Name
    Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
    Manufacturer
    Tangible Science LLC
    Date Cleared
    2017-10-18

    (184 days)

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

    Tangible Science LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Etafilcon with Tangible Coating (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. The Etafilcon with Tangible Coating (etafilcon A) TORIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes who may have 5.00 D or less of astigmatism. The Etafilcon with Tangible Coating (etafilcon A) MULTIFOCAL Soft (Hydrophilic) Daily Wear Contact Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 2.50 D of ADD power and may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. The contact lenses should be discarded upon removal.
    Device Description
    The Etafilcon with Tangible Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is available in an aspheric design and manufactured using the cast-molding process. The lenses consist of 58% water and 42% etafilcon A. The lens material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which are crosslinked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The Etafilcon with Tangible™ Coating (etafficon A) Soft (Hydrophilic) Daily Wear Contact Lenses are available in a light blue tint ([Phthalocyaninato(2-)]copper) for visibility and handling. The lenses also contain a Benzotriazole ultraviolet (UV) absorbing monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range (280 to 315 mm), and less than 30% in the UVA range (316 to 380nm). The Etafilcon with Tangible "M Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is treated to incorporate Tangible TM Coating Technology-which is a thin biocompatible polymer that is covalently bonded to the surface of the contact lens. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (etafilcon A) soft hydrophilic contact lens has an aspheric back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; it will return to its proper configuration when completely rehydrated in the proper storage solution. The lenses are supplied sterile in blister packages containing a buffered saline solution. Package labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.
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