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510(k) Data Aggregation
K Number
K012132Device Name
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
Manufacturer
CANTOR & NISSEL LTD.
Date Cleared
2002-05-09
(304 days)
Product Code
NIC
Regulation Number
886.5925Why did this record match?
Product Code :
NIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ChromaGen v3.0 Reading Aid Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes.
Theses lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error. The lenses are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
Device Description
The ChromaGen v3.0 Reading Aid, Soft Contact Lenses are a range of soft lenses with precision tinted I ho on onlying hue and saturation which, when used in combination, have been shown to be of use for patients experiencing visual discomfort when reading. The ChromaGen v3.0 Reading Aid, 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 encoufacturing process, the lens 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 ChromaGen 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 in and paragraph with (pation 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 ChromaGen v3.0 Reading Aid, Soft Contact Lenses tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.
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