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510(k) Data Aggregation
K Number
K023791Device Name
NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR
Manufacturer
Date Cleared
2003-01-10
(58 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
SOFTFOCAL COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NuSoft Spherical (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity.
The NuSoft Toric (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic and have refractive astigmatism of 4.50D or less that does not interfere with visual acuity.
The NuSoft Aspherical (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D that does not interfere with visual acuity.
The NuSoft Bifocal (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic persons with non-diseased eves that are myopic, or hyperopic, and/or presbyopic and have refractive astigmatism of 4.50D or less that does not interfere with visual acuity.
NuSoft Soft Contact lenses may be disinfected with a chemical (not heat) disinfection system.
Device Description
NuSoft (ocufilcon B) Spherical, Toric, Aspherical and Bifocal Soft Contact Lenses for Daily Wear (lathe-cut, clear or visibility tinted)
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