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    K Number
    K203569
    Device Name
    Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
    Manufacturer
    FCI (France Chirurgie Instrumentation) SAS
    Date Cleared
    2021-06-11

    (186 days)

    Product Code
    NCB
    Regulation Number
    886.5700
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gold and Platinum Tapered Weight Eyelid Implants are intended for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
    Device Description
    The Gold and Platinum Tapered Weight Eyelid Implants are implantable devices for the gravityassisted treatment of lagophthalmos by the addition of weight to the upper eyelid. The device is made of either 99.99% purity gold or platinum. Platinum devices can be implanted in patients who are allergic to gold. The Gold and Platinum Tapered Weight Eyelid Implants come in two thicknesses (thin and normal profiles) and in seven different weights ranging from 0.6 g to 1.8 g (in 0.2 g increments). The Gold and Platinum Tapered Weight Eyelid Implants are each provided as a sterilized product.
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    K Number
    K170591
    Device Name
    Altomed Malhotra Platinum Segments
    Manufacturer
    Altomed Limited
    Date Cleared
    2017-06-06

    (98 days)

    Product Code
    MML
    Regulation Number
    886.5700
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Malhotra Platinum Segments are eyelid implants designed for the gravity-assisted treatment of lagophthalmos.
    Device Description
    Sterile, single use, eyelid weight implant segments, used to treat Lagophthalmos to weigh down the upper eye lid to aid closure, used in combinations to achieve optimum result for each patient. The devices are made of 90% platinum 10% iridium, an industry standard alloy utilized for eyelid implants. The segments are rectangular in shape, contoured to the shape of the eye, with suture holes for both linking segments together in a chain and securing segments into position. Two sizes of segments are provided, with total weight customized for patient need by surgeon selection of segment combinations. The min/max combination range is from total 0.4g to total 2.0g. They achieve their intended purpose through gravity, weighing down the upper eyelid.
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    K Number
    K150986
    Device Name
    Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
    Manufacturer
    MEDDEV CORPORATION
    Date Cleared
    2015-08-17

    (125 days)

    Product Code
    MML
    Regulation Number
    886.5700
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
    Device Description
    MedDev Contour™ and ThinProfile™ Eyelid Weight Implants were designed for the treatment of lagophthalmos, i.e. the inability of the eyelid to fully close. This condition is typically due to a degree of facial paralysis. The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are passive implants surgically placed in the eyelid. The density of their construct material (pure gold or platinum) provides the weight necessary to close the eyelid over the eye. The patient can use their functional orbital musculature to keep their eyes open, but have the gravitational assist from the Implant to close the eyelid.
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