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510(k) Data Aggregation

    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
    Why did this record match?
    Product Code :

    NCB

    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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