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510(k) Data Aggregation

    K Number
    K212741
    Device Name
    EZYPOR
    Manufacturer
    FCI (France Chirurgie Instrumentation) SAS
    Date Cleared
    2022-06-24

    (298 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    FCI (France Chirurgie Instrumentation) SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EZYPOR® orbital implants are designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation.
    Device Description
    EZYPOR® orbital implants are high density polyethylene (UHMWPE) implants designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation procedures. The polyethylene material has an open porosity structure of 40 to 60%. The implants are available in six diameter sizes, 12, 14, 16, 18, 20 and 22 mm. EZYPOR® orbital implants are supplied sterile and are sterilized by ethylene oxide.
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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    FCI (France Chirurgie Instrumentation) SAS

    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
    K201892
    Device Name
    Ritleng®+ and Ritleng®+ PVP
    Manufacturer
    FCI (France Chirurgie Instrumentation) SAS
    Date Cleared
    2021-03-11

    (246 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FCI (France Chirurgie Instrumentation) SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RITLENG®+ products are indicated in the treatment of 12 months and older in cases of: - Canalicular pathologies (stenoses, obstructions, lacerations), - Congenital duct obstruction (Hasner valve stenosis), - Dacryocystorhinostomy (conventional or laser).
    Device Description
    The RITLENG®+ is a self-retaining nasal bicanalicular intubation for the lacrimal ducts. It consists of a silicone tube with two larger diameter portions, connected at each extremity with a PEEK thread guide. Each thread guide has a wide diameter part and a narrow diameter part. The silicone tube may be coated with polyvinylpyrrolidone (PVP) to improve its wettability. The central body of the intubation displays a marking intended for the intubation placement between the lacrimal puncta.
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    K Number
    K201606
    Device Name
    LacriJet®
    Manufacturer
    FCI (France Chirurgie Instrumentation) SAS
    Date Cleared
    2020-12-18

    (186 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FCI (France Chirurgie Instrumentation) SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LACRIJET® from 30 to 50 mm are indicated in the treatment of congenital lacrimal duct obstructions (stenosis of the valve of Hasner) in patients 12 months and older. LACRIJET® with small size (15/20 mm) are indicated in the repair of canalicular lacerations.
    Device Description
    LacriJet® is a monocanalicular intubation device, with self-retaining punctal fixation for the treatment of monocanalicular lacerations and stenoses. The silicone stent acts as a conformer. The shape of the fixation head keeps the probe from migrating and from expulsing.
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    K Number
    K161373
    Device Name
    Nunchaku
    Manufacturer
    FCI (FRANCE CHIRURGIE INSTRUMENTATION)
    Date Cleared
    2016-11-03

    (170 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FCI (FRANCE CHIRURGIE INSTRUMENTATION)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nunchaku stents are intended for use for nasolacrimal intubation in patients 12 months and older. Indications for nasolacrimal intubation performed with the Nunchaku are: - Canalicular pathologies (e.g., congenital or acquired stenosis, laceration) - During dacryocystorhinostomy - Congenital lacrimal duct obstruction
    Device Description
    The Nunchaku is a bicanalicular intubation device for the treatment of epiphora in patients 12 months and older. The device consists of two lateral silicone tubes connected to a silicone body that is delivered pre-mounted on two guides facilitate insertion of the Nunchaku and are completely removed once insertion of the device is complete. The Nunchaku comes in two different model lengths (90 or 105 mm depending on length of tube required) and is provided as a sterilized product.
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