Profile: Topcon Corporation is an ISO certified company. Our eye care products include retinal camera, optical coherence, tomography, tonometer, slit lamp, operation microscope, specular microscope, digital imaging system, vision tester, lens edger, chart projector, auto refractometer, and lens meter. We market systems and equipment used in eye diagnosis, treatment and processing glass lenses to maintain the eyes, which are precision sensors of lights. Our auto chart projector provides improved sharp and clear image projection and fast chart rotation. A cordless remote controller allows instant projection of the 30 test charts at a rate of 0.03 seconds per frame. In addition, the ACP-8 can offer 3 x 5 character charts with a wide projection size (330 x 270) for fast and efficient testing.

FDA Registration Number: 9614661
US Agent: James Lorkowski / Topcon Medical Systems, Inc.
Phone: +1-(201)-599-5187  Fax: +1-(201)-599-5248  E-Mail:

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• 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 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 Ophthalmic Chair (FDA Code: HME / 886.1140) An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit or recline during ophthalmological examination or treatment.

• AC-Powered Perimeter (FDA Code: HOO / 886.1605)

• AC-Powered Stereoscope (FDA Code: HJQ / 886.1870) A stereoscope is an AC-powered or battery-powered device that combines the images of two similar objects to produce a three-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle deviation), evaluate binocular vision (usage of both eyes to see), and guide a patient's corrective exercises of eye muscles.

• AC-Powered Tonometer (FDA Code: HKX / 886.1930) A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

• Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP / 868.5150) An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

• Angiography Device

• Arterial Catheters

• AV Shunt Accessories (FDA Code: KNZ / 876.5540) A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

• Cardiopulmonary Bypass Adaptor (FDA Code: DTL / 870.4290) A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

• Catheters

• Chair with Casters (FDA Code: INM / 890.3100) A mechanical chair is a manually operated device intended for medical purposes that is used to assist a disabled person in performing an activity that the person would otherwise find difficult to do or be unable to do. Examples of mechanical chairs include the following: A chair with an elevating seat used to raise a person from a sitting position to a standing position and a chair with casters used by a person to move from one place to another while sitting.

• 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.

• Cosmetic Surgery, Needles & Syringes

• Cosmetic Surgical Instruments, Catheters

• Diagnostic Angiography

• Diagnostic Condensing Lens (FDA Code: HJL / 886.1380) A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye.

• Digital Imaging Systems

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 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 Syringes

• Doppler optical coherence tomography (FDA Code: OBO / 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.

• Endoscopy Devices

• Endoscopy Instruments, Straight Fan Retractor

• Endoscopy Recording Systems

• Enteral Irrigation Kit w/Piston Syringe

• Esophageal Balloon Catheters

• Esophageal Catheters

• Exam Chairs

• Examination Couches

• Female External Catheters

• Female Indwelling Catheters

• Fistula Needle (FDA Code: FIE / 876.5540)

• Functional Optical Coherence Tomography (FDA Code: OBO / 886.1570)

• Glass Syringes, Reusable

• Hemodialysis Blood Circuit Accessories (FDA Code: KOC / 876.5820) A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

• Hypodermic Syringes

• Instrument Tables

• Intravenous Administration Kit (FDA Code: FPA / 880.5440) An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

• Magnifying Spectacle (FDA Code: HOI / 886.5840) Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.

• Manual Lensmeters

• Manual Non Powered Refractor with Phoropter (FDA Code: HKN / 886.1770) A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.

• Manual Ophthalmic Instrument Table (FDA Code: HRK / 886.4855) An ophthalmic instrument table is an AC-powered or manual device on which ophthalmic instruments are intended to be placed.

• Manual Pupillometer (FDA Code: HLH / 886.1700) A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.

• Medical Syringes, Reusable

• Needles

• Needles & Guidance Systems

• Needles & Needle Guidance Systems