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510(k) Data Aggregation

    K Number
    K992054
    Device Name
    ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS
    Date Cleared
    1999-07-07

    (20 days)

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

    ADVENTURES IN COLOR TECHNOLOGY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ADVENTURE TINTS PROSTHETIC Tinted Soft Contact lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected using a chemical disinfection system only.
    Device Description
    The ADVENTURE TINTS PROSTHETIC Tinted Soft Contact Lenses are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The ADVENTURE TINTS PROSTHETIC contact lenses are tinted to the eyecare professional instructions. The prosthetic color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5, reactive blue 21, reactive blue 19, reactive blue 4. reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The prosthetic lens tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens. Tint Patterns Available: 1. Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm. 2. Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments. 3. Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm increments. 4. Tinted Jens with Black Pupil. Uses the Adventure Tints tinted contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.
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    K Number
    K984098
    Device Name
    ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS
    Date Cleared
    1999-05-10

    (174 days)

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

    ADVENTURES IN COLOR TECHNOLOGY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ADVENTURE TINTS, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The ADVENTURE TINTS visitint provides for ease of patient handling and does not effect iris color. Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens may be disinfected using a chemical disinfection system only.
    Device Description
    ADVENTURE TINTS, Color Enhanced Tinted Soft Contact Lens are color enhanced soft contact lenses that have been previously prescribed for a specific patient. They have been supplied to Adventure in Colors to be modified by a tinting process using color additives that have been listed as safe for contact lenses in accordance with the FDA's color additive regulations. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The ADVENTURE TINTS, Color Enhanced Tinted Soft Contact Lens are available in a light, medium or dark shade of the following enhance colors; Blue, Deep Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet (Hot Pink), and Amber. ADVENTURE TINTS. Color Enhanced Tinted Soft Contact Lens are also available in a standard blue visibility-handling tint. The color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5. reactive blue 19, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The following are tint patterns available to the practitioner: - Clear Pupil diameter (2.00mm to 8.00mm), standard is 4.5mm. ・ - Annular (iris) diameter (8.00mm to 13.5mm), standard is 11.5mm diameter. l - Black pupil diameter (2.0mm to 12.5mm), standard is 4.0mm diameter. - - Occluder diameter (2.00mm to 12.5mm). a
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