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510(k) Data Aggregation

    K Number
    K222541
    Device Name
    Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
    Manufacturer
    Bausch & Lomb Incorporated
    Date Cleared
    2022-12-06

    (106 days)

    Product Code
    LPN, MRC
    Regulation Number
    886.5928
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bausch + Lomb Preservative Free Lubricating and Rewetting Drops are indicated for use to lubricate and rewet soft (hydrophilic) contact lenses, including silicone hydrogel as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lenses during wear. The product may be used with daily or extended wear, and disposable lenses.
    Device Description
    Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution that contains boric acid, sodium borate, potassium chloride, erythritol, poloxamine, glycerol and hyaluronan for lubricating and rewetting soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and rigid gas permeable contact lenses during wear.
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    K Number
    K221263
    Device Name
    Aqua Naina Plus Sterile Saline Solution
    Manufacturer
    Chemtex USA Inc.
    Date Cleared
    2022-10-12

    (163 days)

    Product Code
    LPN, MRC
    Regulation Number
    886.5928
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aqua Naina Plus Sterile Saline Solution: The Aqua Naina Plus Sterile Saline Solution for single use is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses. The Aqua Naina Plus Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. Aqua Naina Sterile Saline Solution: The Aqua Naina Sterile Saline Solution is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion and following proper lens disinfection as recommended by the eye care practitioner. The Aqua Naina Sterile Saline Solution may be used as needed throughout the day to rinse contact lenses and contact lens cases.
    Device Description
    Aqua Naina Plus Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear (colorless) aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Plus Sterile Saline Solution has pH of 7.00 to 7.40 and Osmolality of 290 to 320 mOsmol/kg. The Sterile Saline Solution is packed in single dose 1 fl oz (30 ml) high density polyethylene (HDPE) container with a tamper evident seal. Aqua Naina Plus Sterile Saline Solution is for single use only. Aqua Naina Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear (colorless) aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Sterile Saline Solution has pH of 7.00 to 7.40 and Osmolality of 290 to 320 mOsmol/kg. The Sterile Saline Solution is packed in a multidose 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.
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    K Number
    K210300
    Device Name
    VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
    Manufacturer
    VueSonic, LLC
    Date Cleared
    2021-04-01

    (57 days)

    Product Code
    LYL, MRC
    Regulation Number
    886.5928
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology. The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
    Device Description
    The VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning Systems are cleaning systems for contact lenses. Both devices consist of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens. The systems are designed to mimic human hand rubbing. This is done by the 3D multi-frequency modulated stereo power source and corresponding intelligent control circuit, which make a uniform three-dimensional relative movement between the damping heads and cleaning cushion. The proposed device consists of two versions: - For Rigid Lenses, VueSonic Advance 2 Contact Lens Cleaning System; and - For Soft and Hybrid Lenses, VueSonic One Contact Lens Cleaning System.
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    K Number
    K200416
    Device Name
    Boston One Step Liquid Enzymatic Cleaner
    Manufacturer
    Bausch & Lomb Incorporated
    Date Cleared
    2020-09-23

    (216 days)

    Product Code
    MRC
    Regulation Number
    886.5918
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses during (wetting, soaking, and disinfecting) with Boston Conditioning Solution or Boston ADVANCE Comfort Formula Conditioning Solution.
    Device Description
    Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is a preservative free sterile, aqueous solution containing proteolytic enzyme (subtilisin) as the active ingredient, and glycerol.
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    K Number
    K201069
    Device Name
    VibrantVue Scleral Saline
    Manufacturer
    Dry Eye Innovations, LLC
    Date Cleared
    2020-07-31

    (100 days)

    Product Code
    MRC
    Regulation Number
    886.5918
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vibrant Vue Scleral Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The VibrantVue Scleral Saline is for rinsing large diameter (scleral) rigid gas permeable (RGP) contact lenses prior to lens insertion. This solution may also be used as an insertion for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
    Device Description
    The VibrantVue Scleral Saline is a sterile, preservative-free, unbuffered saline solution in a single dose 5 ml vial. The VibrantVue Scleral Saline is a 0.9 % saline solution that conforms to the requirements of USP saline. The rinsing solution removes loose debris and lens cleaners off rigid gas permeable (RGP) contact lenses following proper disinfection as recommended by the eye care practitioner. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day.
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    K Number
    K200747
    Device Name
    PuriLens Plus Preservative Free Saline
    Manufacturer
    The LifeStyle Company, Inc.
    Date Cleared
    2020-05-15

    (53 days)

    Product Code
    LPN, MRC
    Regulation Number
    886.5928
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PuriLens Plus Preservative-Free Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. PuriLens Plus Preservative-Free Saline is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
    Device Description
    The PuriLens Plus Preservative Free Saline is a sterile, buffered saline solution for rinsing and storing contact lenses. The solution is buffered to roughly physiological pH and has an osmolarity similar to that of human tears. The product is sold over-the-counter in various packaging configurations. The current generation of the product, Purilens Saline Solution, was cleared under K002319 in 2000, and has been legally marketed in the US since that time. This 510(k) application is to expand the indications for use to include use with rigid gas permeable lenses. There is no change in the device design, formulation, or manufacturing. The labeling will be revised with the new indications.
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    K Number
    K191872
    Device Name
    Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
    Manufacturer
    Menicon Co., Ltd.
    Date Cleared
    2020-03-02

    (234 days)

    Product Code
    LPN, MRC
    Regulation Number
    886.5928
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.
    Device Description
    The Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution system consists of: Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case. The lens case consists of a transparent cup and a lens holder-lens case cap assembly with a neutralizer catalyst disk. Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case must always be used together. The preservative free, aqueous Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution contains: hydrogen peroxide 3%, phosphonic acid compound (stabilizer), citric acid, polyethylene glycol, sodium chloride, sodium hydroxide, and phosphate (buffer system).
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    K Number
    K190674
    Device Name
    REFRESH RELIEVA For CONTACTS
    Manufacturer
    Allergan, Inc
    Date Cleared
    2019-08-08

    (146 days)

    Product Code
    LPN, MRC
    Regulation Number
    886.5928
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REFRESH® RELIEVA™ FOR CONTACTS is indicated to lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.
    Device Description
    REFRESH® RELIEVA™ FOR CONTACTS is a sterile, buffered, isotonic, preserved solution. This aqueous formulation includes carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%). The solution may also contain hydrochloric acid and/or sodium hydroxide to adjust pH. All ingredients except for Purite are compendial grade (USP/NF/Ph Eur). The product is supplied in a teal colored, low density polyethylene (LDPE) multi-dose bottle and tip with a teal colored high impact polystyrene (HIPS) cap. The bottles are further packaged in paper cartons with a patient information insert.
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    K Number
    K191795
    Device Name
    AOCup Lens Case with AODisc
    Manufacturer
    Alcon Laboratories, Inc.
    Date Cleared
    2019-07-31

    (28 days)

    Product Code
    LPN, LRX
    Regulation Number
    886.5928
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered 3% hydrogen peroxide contact lens solution.
    Device Description
    The device is a specialized lens case consisting of a transparent cup with a connected unit of screw cap, lens holders (baskets) and platinum-coated neutralization disc. The platinum catalyst coating and shape of the plastic disc are designed to effectively neutralize hydrogen peroxide in the lens care system to harmless water and oxygen gas.
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    K Number
    K182984
    Device Name
    MaxiTears Contacts PF
    Manufacturer
    Omnivision AG
    Date Cleared
    2019-07-24

    (268 days)

    Product Code
    MRC, LPN
    Regulation Number
    886.5918
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MaxiTears® CONTACTS PF eye drops have been formulated for use with both soft and rigid gas permeable (RGP) contact lenses, to rewet lenses before insertion and lubricate lenses during wear. It also relieves minor irritation, discomfort, dryness, blurring and itchiness, which may occur while wearing your lenses.
    Device Description
    The MaxiTears CONTACTS PF are ready-to-use, isotonic, sterile eye contact lens care products (lubricants) intended to moisturize and lubricate the lens drops in eyes to reduce minor symptoms of dry eyes such as burning or itching. The intended use of these contact lens rewetting solutions is to alleviate the symptoms of dryness, discomfort, and minor irritation caused by ocular fatigue induced by the wearing of contact lenses, for example, by environmental conditions (dust, smoke, dry heat, air conditioning, wind, cold) tiredness or extended computer screen use. The MaxiTears CONTACTS PF solution can be used with all types of contact lenses, except contact lenses manufactured from Efrofilcon A, and are intended for repeated use over an extended period of time. The MaxiTears CONTACTS PF solution it to be introduced to the US-market as an Over the Counter (OTC) medical device similar to other 510k-cleared lens drop lubricants (and identical to predicate Blink CL Lubricant Eve Drops K032030), sold as OTC medical device in retail outlets and through the internet. OmniVision AG is offering the MaxiTears CONTACTS PF solution as Over the Counter device: - MaxiTears' CONTACTS PF is a medium viscous preservative-free solution packaged in single-use . ampoules (single-dose units -SDU). They are supplied as single-dose unit plastic ampoules designed to administer one drop and then to be discarded. They are indicated for users with a known history of allergy to preservatives and those who wear contact lenses.
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