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510(k) Data Aggregation
K Number
K060821Device Name
SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES
Manufacturer
SPECIALEYES LLC
Date Cleared
2006-05-18
(52 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
SPECIALEYES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Special Eyes 59 (hioxifilcon A) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.
The Special Eyes 49 (hioxifilcon B) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.
Device Description
SpecialEyes 59 and 49 soft contact lenses are hemispherical shells available in spherical or toric lens designs and in. hioxifilcon A and hioxifilcon B materials.The lenses are fabricated by lathe cutting hioxifilcon A and hioxifilcon B materials both non-ionic copolymers of 2hydroxeyethylmethacrylate (2-HEMA) and Glycerol Methacrylate (GMA). The water content by weight is 49% for hioxifilcon B and 59% for hioxifilcon A. when immersed in normal saline. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent optical surface.
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