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510(k) Data Aggregation
K Number
K980818Device Name
POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)
Manufacturer
STEPHEN A. DUNN, INC.
Date Cleared
1998-03-30
(27 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
STEPHEN A. DUNN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism in not-aphakic persons with non-diseased eyes.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.
Device Description
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and methacrylic acid crosslinked with EGDMA, which yield the appearance of lenses, which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the comea and center over the apex of the cornea to provide corrective refraction of functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness), presbyopia and astigmatism (multiple foci). Each lens provides corrective power, which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Spherical and aspheric curves as well as beveled edge configurations are built into the lens for aiding in lens centration and comfort as well as providing additional add power for near and blocking spherical aberration.
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K Number
K953807Device Name
DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
Manufacturer
STEPHEN A. DUNN, INC.
Date Cleared
1996-02-14
(190 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
STEPHEN A. DUNN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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