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510(k) Data Aggregation

    K Number
    K240095
    Device Name
    CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
    Manufacturer
    Shanghai Care Us Medical Product Co., Ltd.
    Date Cleared
    2024-10-09

    (271 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "CAREUS Contact Lens Case" is a device intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.
    Device Description
    "CAREUS Contact Lens Case" is a medical device for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lid. The case body is based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing. "CAREUS Contact Lens Cases" have six different models, differ in dimension, case color, and packaging. The exterior of the cases total have 9 colors: white, pink, yellow, green, light green, red, purple, blue, and transparent (no color). Contact lenses can be fully immersed into the well from both models accommodates all lenses currently being sold in the market. The bottom of each well is marked with L (left) or R (right). CAREUS Contact Lens Cases are made of polypropylene.
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    K Number
    K231123
    Device Name
    Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
    Manufacturer
    Phoenix Innovative Healthcare Manufacturers Pvt. Ltd.
    Date Cleared
    2023-08-30

    (132 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection.
    Device Description
    There are three models of the Phoenix Contact Lens Case: CL-01 "Dome Top Flat Pack" - made with LDPE and has 1.5ml wells on each side CL-02 "Classic Flat Pack" - made with LDPE and has 1.5 ml wells on each side CL-03 "Sunglass Shape Flat Pack" made with Polypropylene and has 2.0 ml wells on each side All three models have hinged self sealing caps and are available in white, black, blue, orange, green, and natural. The Phoenix contact lens cases are intended for storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. It is not to be used with heat disinfection.
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    K Number
    K173538
    Device Name
    Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
    Manufacturer
    Alcon Laboratories, Inc.
    Date Cleared
    2017-12-04

    (19 days)

    Product Code
    LRX, LPN
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LRX

    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
    K172925
    Device Name
    Contact Lens Case, Model: A-1, B-1
    Manufacturer
    P L Overseas Limited
    Date Cleared
    2017-11-30

    (66 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection. Use for storage during chemical disinfection only. Do not use during heat disinfection.
    Device Description
    The Contact Lens Case is a lens case product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic), hard and rigid gas permeable contact lenses during chemical disinfection. The Case is to be designed during chemical disinfection only. No designed for heat disinfecting system. The Contact Lens Case includes A-1 and B-1 two models. Both have adopted the same structure design, consisting of two parts: holder and cover. The holder is based with adjoining dual wells for the containment of fluid, and two covers are designed for screwing. At the same time, the bottom of each well is marked with L (left) and R (right) letters, and the covers are also labeled with L (left) and R (right) letters. The Contact Lens Case is simple with a well volume of 4.2mL $\pm$0.15. This volume capacity can provide sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately over the lenses for cleaning.
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    K Number
    K173365
    Device Name
    Bausch + Lomb Boston Scleral Lens Case
    Manufacturer
    Bausch & Lomb Incorporated
    Date Cleared
    2017-11-17

    (22 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bausch + Lomb Boston® Scleral Lens Case is indicated for storage of gas permeable (fluoro scrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.
    Device Description
    Bausch + Lomb Boston® Scleral Lens Case consists of a polypropylene cap and polypropylene body for storage of gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.
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    K Number
    K171539
    Device Name
    Contact Lens Case
    Manufacturer
    E-Link Plastic & Metal Industrial Co.,Ltd
    Date Cleared
    2017-07-14

    (49 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Contact Lens Case is a device intended for storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.
    Device Description
    The Contact lens case is medical device for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lids. The case body based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing. All the four variant models of this device have a capacity of 5.3 ml to allow contact lenses fully immersed into the well, and the well from these models accommodates all lenses currently being sold in the market. In addition, the contact lens case are made of polypropylene (96%) and Polyethylene (4%), which allow the same design principle with the same intended use. Speaking of the labeling, the inner lids of the case are marked with L (left) or R (right), meanwhile the bottom of each well is also labeled with L (left) or R (right) to distinguish the left and right lenses. In addition, at the bottom of the case body, two sides of which have labeled REPLACE MONTHLY respectively to remind user to replace the contact lens case at least once every month.
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    K Number
    K171163
    Device Name
    Contact Lens Case Round Glasses
    Manufacturer
    FiftyTwoWays Ltd
    Date Cleared
    2017-06-27

    (68 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CONTACT LENS CASE ROUND GLASSES is intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.
    Device Description
    The Contact Lens Case Round Glasses is leak-proof and made from durable plastic with secure, snap lids. Note: can be used with hard and soft contact lenses; for chemical disinfection only; rinse case thoroughly before initial use; replace contact case every 2 months. The secure snap lids are connected to the body by stainless steel hinges and securely close by use of the silicon seal within the plastic Each compartment has a capacity of 4,4ml and diameter of 26,5mm and an overall dimension of 76mm x 29mm x 17mm The Case body is in White Color and the Lids in Black Color with transparent windows. Contact lenses can be fully immersed in each compartment, and each compartment fit all standard lenses currently being sold in the market. The side of each compartment is marked with L (left) or R (right)
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    K Number
    K162869
    Device Name
    Contact Lens Case
    Manufacturer
    Ningbo Yinzhou Zonghai Artware Co., Ltd.
    Date Cleared
    2016-12-09

    (57 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For storage of soft (hydrophilic), hard and rigid gas permeable contact lenses during chemical disinfection. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.
    Device Description
    The Contact Lens Case is a simple device made with a polypropylene base and a polyethylene lid to store soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. This device is manufactured only for chemical disinfections with approved chemical cleaning agents to clean contact lenses. The physical style is simple with a base volume of 4.8 milliliter and dimensions of 6.25 mm wide and 9.25 mm high. This provides sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately cover the lenses for cleaning.
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    K Number
    K160005
    Device Name
    Contact Lens Case (multiple brand name)
    Manufacturer
    DANYANG CHANXIN GLASSES CASES FACTORY
    Date Cleared
    2016-06-07

    (155 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic) contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.
    Device Description
    Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft(hydrophilic) contact lenses while not being worn. This device is not sterile and not for heat-disinfection. Use only with chemical disinfection. There are two main series includes the variant model DC-2001, DC-3001 and DC-6001, the other includes DC-7001 and DC-8001. All these five variant models are made of Polypropylene, which follow the same design principle with the same intended use. All the five variant models of this device have a capacity of over 1.5 ml in each case well. And the inner height of the all wells exceeds 8.5 mm. With regard to the Center Thickness of the normal hydrophilic and hydrophobic contact lens will not outnumber 8.5 mm, the capacity is sufficient for contact lens to be fully immersed under use condition.
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    K Number
    K142717
    Device Name
    Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case
    Manufacturer
    Ni Hau Industrial Co., Ltd.
    Date Cleared
    2015-05-07

    (226 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For storage of soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfection. Use for storage during chemical disinfections only. DO NOT USE WITH HEAT.
    Device Description
    The contact lens cases in submission are intended to be used to store soft (hydrophilic) and hard contact lenses during chemical disinfection only. These are not to be used in heat disinfection. There are 2 parts to each contact lens case, the main body/base with two wells, and two screw-on lids. In order to store contact lenses with disinfection solution, the wells for storage need to be leak-proof, which is designed so by the screw construction of the lids. The plastic that is used in all four contact lens cases is Acrylonitrile Butadene Styrene (Product Name: Polylac ® PA-707, manufactured by Chi Mei Corporation, please refer MSDS attached: Attachment 1), which is a durable plastic that is insoluble in water and can be used for at least two months continuous use. The cat contact lens case is black, with white printed on the lids. The color pigment used in the case is PLASBLAK® UN2014 (Supplier: Cabot Plastics, please refer MSDS attached: Attachment 2). This pigment is insoluble in water. The sunglasses contact lens case is white, with black labels on the lids. The color pigment used in the case is DuPont™ Titanium Dioxide Pigment - Plastics Grade/Type : R-350 (Supplier: DuPont, please refer MSDS attached: Attachment 3). This pigment is insoluble in water. The 1st contact lens case is green, with clear uncolored lids. There are 2 color pigments used in the green body (1) PV Fast Green GNX (Supplier: Clariant Chemicals (India) Limited, please refer MSDS attached: Attachment 4) and (2) MACROLEX Yellow G Granulate (Supplier: Bayer AG, please refer MSDS attached: Attachment 5). These pigments are insoluble in water. The Geeky eyes contact lens case is red with black glasses. The color pigment used in the red case is 13575 Orange Color Powder (Supplier: Summit Color Co., Ltd., please refer MSDS attached: Attachment 6). This pigment is insoluble in water. The individual well capacity of each contact lens are: cat contact lens case 2.8ml, sunglasses contact lens case 2.5ml, 1* contact lens case 3ml, geeky eyes contact lens case 2.8ml. The capacities aforementioned are sufficient for a contact lens to be fully soaked in the disinfection liquid. At the base of the cat contact lens case and the sunglasses contact lens case, in each well there is L and R embossed to help users differentiate the left and right lenses. The geeky eyes contact lens case also has the L and R markings on the side of the casing outer. The 1d contact lens case does not have L and R markings on it as the two wells are situated one above and one below the disc so it is unlikely to mix up the two wells during use. Through use, the material of the contact lens case may come into contact with the user's eyes indirectly. The user will need to put contact lenses with chemical disinfecting liquid into the contact lens case for storage. Therefore we have used a plastic material and colorants that are insoluble in water so that it will not come in contact with one's eyes. These contact lens cases are intended for the storage of soft (hydrophilic) and hard contact lenses. The case should ensure the fluids contained do not leak. These cases are for the storage of chemical disinfecting fluids with contact lenses only, they are not to be used in heat disinfection. These are not sold sterile, so the packaging should have instructions written on them to "Rinse the case thoroughly with clean solution before use". It is recommended to replace the contact lens case at least every 3 months.
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