FCI Ophthalmics

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Web: http://www.fci-ophthalmics.com
E-Mail:
Address: P.O. Box 465, Marshfield Hills, Massachusetts 02051, USA
Phone: +1-(781)-826-9060 | Fax: +1-(781)-826-9062 | Map/Directions >>
 
 

Profile: FCI Ophthalmics concentrates in ophthalmic surgical devices. Our products include retina, cataract, lid repair, orbital implants, lacrimal stents & tubes, and dry products. The orbital implant products offers Bioceramic orbital implants, sphere introducers, disposable sizers, and other ophthalmic surgical devices. The bioceramic orbital implant includes porous, strong, rapid & complete fibrovassularization, light weight, easy to insert, and low exposure rate.Our eyejet is a preloaded capsular tension ring on a disposable injector for cataract surgery. Our ProLong™ absorbable long term plug provides relief from short term dry eye conditions.

The company was founded in 1996, has revenues of USD 1-5 Million and is ISO 9002, CE certified.

FDA Registration Number: 1225124

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• AC- powered Corneal Topographers (FDA Code: MMQ / 886.1350)
A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.
• AC-Powered Automatic Perimeter (FDA Code: HPT / 886.1605)
A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
• AC-Powered Biomicroscope Slit Lamp (FDA Code: HJO / 886.1850)
An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.
• AC-Powered Keratome (FDA Code: HNO / 886.4370)
A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.
• AC-Powered Lens Measurment Instrument (FDA Code: HLM / 886.1425)
A lens measuring instrument is an AC-powered device intended to measure the power of lenses, prisms, and their centers (e.g., lensometer).
• AC-Powered Ophthalmic Camera (FDA Code: HKI / 886.1120)
An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
• AC-Powered Ophthalmoscope (FDA Code: HLI / 886.1570)
An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.
• AC-Powered Perimeter (FDA Code: HOO / 886.1605)
• Battery-Powered Ophthalmoscope (FDA Code: HLJ / 886.1570)
• Bioceramic Orbital Implants
• Capsular Tension Rings
• Collagen Punctum Plugs
• Colposcope and Accessories (FDA Code: HEX / 884.1630)
A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.
• Confocal Scanning Laser Ophthalmoscope (FDA Code: MYC / 886.1570)
• Conformers
• Cordless Pupillometers
• Corneal Radius Measurement Instrument (FDA Code: HJB / 886.1450)
A corneal radius measuring device is an AC-powered device intended to measure corneal size by superimposing the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye gauge magnifier.
• Diagnostic Polymethylmethacrylate Contact Lens (FDA Code: HJK / 886.1385)
A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.
• Diagnostic/Surgical Loupe (FDA Code: FSP / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
• Disposable Surgical Drape (FDA Code: KKX / 878.4370)
A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.
• Disposable Vitrectomy Lenses
• Doppler optical coherence tomography (FDA Code: OBO / 886.1570)
• Double Ended Lacrimal Dilator
• Double Ended Lacrimal Probe
• Dry Eye Products, Snug PlugsT
• Egg-Shaped Bioceramic Orbital Implants
• Endocapsular Ring (FDA Code: MRJ)
• Evisceration Scoops
• Expansive Iris Dilator & Accessories (FDA Code: MMC / 886.4150)
A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.
• Extended Duration Punctum Plugs
• External Eyelid Weights (FDA Code: MML / 886.5700)
• Extra-Ocular Orbital Implant (FDA Code: HQX / 886.3340)
An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.
• Eye Products, Ptosis Strips
• Eye Sphere Implant (FDA Code: HPZ / 886.3320)
An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
• Eyelid Implants
• Eyelid Procedures, Gold Weighted Eyelid Implants
• Functional Optical Coherence Tomography (FDA Code: OBO / 886.1570)
• General & Plastic Surgery Surgical Microscope (FDA Code: FSO / 878.4700)
A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
• Gold Weight Eyelid Implants
• Gold Weighted Eyelid Implants
• Hand-held Pupillometers
• Implant Inserters
• Infrared Pupillometers
• Lacrimal Dilator (FDA Code: HNW / 886.4350)
A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
• Lacrimal Duct Surgery Devices
• Lacrimal Intubation and DCR (Dacryocystorhinostomy)
• Lacrimal Probes (FDA Code: HNL / 886.4350)
• Lacrimal Punctum Plug
• Lacrimal Stents And Intubation Sets (FDA Code: OKS)
• Lacrimal System, Punctal Gauges

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