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510(k) Data Aggregation

    K Number
    K183200
    Device Name
    iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
    Manufacturer
    C&E GP Specialist, Inc.
    Date Cleared
    2019-01-09

    (51 days)

    Product Code
    MUW
    Regulation Number
    886.5916
    Why did this record match?
    Product Code :

    MUW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
    Device Description
    The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D or roflufocon E-with the following properties: Refractive Index, Light Transmission (clear), Light Transmission (tinted), Wetting Angle (Dynamic contact receding angle), Specific Gravity, Oxygen Permeability (Dk) ISO/FATT Method, Visitint lenses contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D. The lenses are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Spherical Power, Secondary Curves, Peripheral Curves, Multifocal Power.
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    K Number
    K160859
    Device Name
    OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
    Manufacturer
    CONTAMAC LTD.
    Date Cleared
    2016-07-13

    (106 days)

    Product Code
    MUW
    Regulation Number
    886.5916
    Why did this record match?
    Product Code :

    MUW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OPTIMUM GP OK contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
    Device Description
    The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3 - Hexafluoroisopropy] Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acid cross-linked with Ethylene Glycol Dimethacrylate. The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP OK lenses is the PolyVial /PolyPack Contact Lens Case. When shipped "wet", the OPTIMUM GP OK lenses may be packaged and shipped in the Optimum Cleaning, Disinfecting and Storage (CDS) GP solution. The active ingredients in Optimum GP Cleaning Disinfecting and Storage solution are Lauryl salt of imidazoline, octylphenoxypolyethoxyethanol, and preserved with benzyl alcohol 0.3% and disodium edetate 0.5%. The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6. C.I. Solvent yellow No. 18. and FD&C Red No. 17. In the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV Blocker is 2,2 -Dihydroxy-4,4'dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280nm – 315nm and 95% in the UVA range of 316 – 380nm.
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    K Number
    K010109
    Device Name
    FLUOROPERM 151-OK, PARAGON HDS 100-OK
    Manufacturer
    PARAGON VISION SCIENCES
    Date Cleared
    2001-02-28

    (47 days)

    Product Code
    MUW
    Regulation Number
    886.5916
    Why did this record match?
    Product Code :

    MUW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003933
    Device Name
    BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
    Manufacturer
    POLYMER TECHNOLOGY
    Date Cleared
    2001-02-16

    (58 days)

    Product Code
    MUW
    Regulation Number
    886.5916
    Why did this record match?
    Product Code :

    MUW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000224
    Device Name
    FLUROPERM 60-OK, PARAGON HDS-OK
    Manufacturer
    PARAGON VISION SCIENCES
    Date Cleared
    2000-04-17

    (84 days)

    Product Code
    MUW
    Regulation Number
    886.5916
    Why did this record match?
    Product Code :

    MUW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K973697
    Device Name
    AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY
    Manufacturer
    AIRPERM, INC.
    Date Cleared
    1998-04-08

    (194 days)

    Product Code
    MUW
    Regulation Number
    886.5916
    Why did this record match?
    Product Code :

    MUW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CONTEX OK™ (siflufocon A) Rigid Gas Permeable Contact Lens for Orthokeratology is indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lens is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 3.00 diopters. The lens may be disinfected using a chemical disinfection system only. Note: To maintain the orthokeratology effect of myopia reduction lens wear must be continued on a prescribed wearing schedule.
    Device Description
    The CONTEX OK™ (orthokeratology) contact lens is a rigid gas permeable contact lens in a reverse geometry design. The lens material siflufocon A, is a fluoro silicone acrylate polymer which contains D & C Green #6 as a color additive. The CONTEX OK™ (orthokeratology) contact lens has the following dimensions: Chord Diameter................Approximately 6.5 to 13.0 mm Center Thickness for Low Minus Lens..................................0.10 to 0.30 mm for Plus Lens:........................................0.20 to 0.70 mm Base Curve........................................6.50 to 11.00 mm Secondary Curves........................ 0.1 to 2 mm. Flatter or Steeper than Base Curve Peripheral Curves........................ 0.1 to 2 mm. Flatter or Steeper than Base Curve Powers........................................-10.00 to +5.00 Diopters Aspheric Lens Eccentricity ................................................................................................................................................... (Oblate, Prolate or Tangent Conic) The physical properties of the lens are: Refractive Index...... 1.43 (Nd at 25°) Light Transmittance... > 92.5% (370-760 nm) Wetting Angle ... 24.0 (Contact Receding Angle) Specific Gravity.... 1.25 Hardness.... 82 Water Content... <1% Oxygen Permeability.....(cm²/sec) (ml O₂ x Hg) 81 x10⁻¹¹Dk at 35°C CONTEX OK™ (orthokeratology) contact lenses produce a temporary reduction of myopia by changing the shape (flattening) of the cornea, which is elastic in nature. Flattening the cornea reduces the focusing power of the eye, and if the amount of corneal flattening is properly controlled, it is possible to bring the eye into correct focus and compensate for myopia. Contact lenses rest directly on the corneal tear layer and can influence the corneal shape. After the contact lens is removed, the cornea retains its altered shape for part or all of the remainder of the day. A retainer lens must be used each day to maintain the corneal flattening, or the myopia will revert back to the pre-treatment level.
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