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510(k) Data Aggregation

    K Number
    K061404
    Device Name
    MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    2006-08-07

    (80 days)

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

    FCI OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated in initial surgery in the treatment of monocanalicular lacerations and stenoses requiring intubation. Further indications are: Congenital lacrimal duct obstructions Canalicular lacerations After treatment of canaliculitis with concretions when curettage of a canaliculus has been performed. After clacryocystorhinostomy Epiphora
    Device Description
    Not Found
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    K Number
    K061398
    Device Name
    SNUG PLUG PUNCTUM PLUG
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    2006-07-11

    (53 days)

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

    FCI OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ocular dryness. The Snug Plug punctum plug is used to occlude the punctum in the treatment of ocular dryness.
    Device Description
    Not Found
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    K Number
    K041869
    Device Name
    SELF RETAINING BICANALICULUS INTUBATION SET
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    2004-11-18

    (132 days)

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

    FCI OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bicanalicular intubation is indicated in treatments of epiphora in adults (not to be used in infants), particularly in cases of: - Meatic pathologies (meatic atresia) - Canalicular pathologies (canalicular stricture)
    Device Description
    Self-Retaining Bicanaliculus Intubation Set
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    K Number
    K023758
    Device Name
    BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    2003-09-17

    (313 days)

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

    FCI OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transnasal Lacrimal Stent is indicated in treatments of epiphora treated by dacryocystorhinostomy. Dacryocystorhinostomy (DCR) is the common surgical procedure used to correct nasolacrimal duct obstruction.
    Device Description
    Not Found
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    K Number
    K023400
    Device Name
    FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    2003-08-22

    (317 days)

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

    FCI OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mesh wrapped Bioceramic orbital implants are designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.
    Device Description
    Mesh Wrapped Bioceramic Orbital Implant
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    K Number
    K030054
    Device Name
    DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    2003-02-26

    (51 days)

    Product Code
    HJK, HMX, HNN
    Regulation Number
    886.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    FCI OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable Vitrectorny Set is used in the context of vitrectorny procedures. The self-blocking infusion cannula with infusion tubing provides the saline solution or balanced saline solution throughout the procedure, ensuring that the eye retains its tonicity. No sutures are required. The knife is used for making a calibrated and non-leaking incision into which the self-blocking infusion cannula is inserted. The lens, used with microscope, facilitates visualization of the retina by canceling the corneal diopter. An edge, which has a frosted ring on its upper side to avoid edge glare effects, allows users to position and move the lens on the cornea with forceps.
    Device Description
    Not Found
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    K Number
    K992294
    Device Name
    BIOCERAMIC ORBITAL IMPLANT
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    2000-04-19

    (287 days)

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

    FCI OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a primary implant for patients who present with eye disease or severe damage such that the eye must be enucleated or eviscerated. An existing orbital implant that is malfunctioning or not satisfying the patient in terms of performance, may call for a secondary implant procedure to install a bio-ceramic orbital implant.
    Device Description
    Bio-ceramic Orbital Implant
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    K Number
    K991238
    Device Name
    FCI CRAWFORD PROBE INTUBATION SETS
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    1999-07-08

    (87 days)

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

    FCI OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Epiphora in infants or adults, particularly in cases of canalicular pathologies (stenosis, obstruction or laceration) dacryocysorhinostomy (conventional or laser) imperforation of the nasolacrimal duct in an infant
    Device Description
    Not Found
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    K Number
    K980816
    Device Name
    RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    1998-09-18

    (199 days)

    Product Code
    HQX
    Regulation Number
    886.3340
    Why did this record match?
    Applicant Name (Manufacturer) :

    FCI OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision
    Device Description
    Not Found
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    K Number
    K980822
    Device Name
    TITANIUM PEG SYSTEM
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    1998-07-09

    (128 days)

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

    FCI OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This system is designed to drill hydroxyapatite orbital implants and place a motility peg for coupling to the artificial eye. It may also be used to replace a previous sleeve or a previous peg.
    Device Description
    Not Found
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