Search Results
Found 1 results
510(k) Data Aggregation
K Number
K024164Device Name
COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT
Manufacturer
Date Cleared
2003-02-12
(57 days)
Regulation Number
886.5916Why did this record match?
Applicant Name (Manufacturer) :
METRO OPTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ComfortKone™ Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical disinfection system.
Device Description
The ComfortKone" Keratoconus Aspheric Contact Lens is fabricated from the hydrophobic contact lens materials (hybufocon A, filotocon A, pemufocon A). When placed on the human cornea, the Comfort Keratoconus Aspheric rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.
The Comfort Kone" is a aspheric contact lens. It is designed to provide optimum comfort and visual acuity to the keratoconus patient. The ComfortKone™ lens design begins with a spherical 4.0 mm ontic zone that fits the peak of the cone and provides for good visual acuity. The lens then thattens into the aspheric curve, which is considered the fitting curve of the lens. The aspheric curve will vary in rate of change depending on how far the keratoconus has advanced and creates optimal corneal alignment. design finishes with two junctioniess peripheral aspheric curves to maintain alignment.
Ask a Question
Ask a specific question about this device
Page 1 of 1