Carl Zeiss Meditec, Inc.,
High Class Dental,
Barnstead International,
more...
Tube shunt surgery is a surgical method to treat glaucoma. Glaucoma is a potentially blinding disease. The major known cause of glaucoma is a relative increase in intraocular pressure, or IOP. The purpose of glaucoma treatment, whether medical or surgical, is to lower the IOP. This surgery implant is comprised of two parts such as tubing and an attached reservoir. Tubing is a portion of which is implanted along the inside of the front of the eye. The distal (furthest from the center) end of the tubing protrudes through the anterior (front) or less commonly, the posterior (rear), chamber of the eye. An attached reservoir is called a plate, which is placed under the conjunctiva of the eye at its equator, or midpoint.
Staar Surgical Company,
New World Medical Inc.,
Optonol Ltd,
more...
Bernell VTP,
Richmond Products, Inc.
Pro Orthopedic Devices,
DENOVO Dental Inc.,
Masel,
more...
Pro Orthopedic Devices,
DENOVO Dental Inc.,
Masel,
more...
Tungsten eye shield is ideal for electron beam treatment. It is suitable for use in electron beam treatment of eyelid tumors. It uses anodized aluminum cap to reduce the electron backscatter to the eyelid. The eye shield can be used without the aluminum cap when placed superficially. Tungsten eye shields have less transmission than other eye shields.
Hurricane Medical,
Medtronic Ophthalmics,
Ellman International, Inc.
Sterilmed, Inc.,
Eye4Vision Ophthalmics Int'l.
Oasis Medical, Inc.,
Anton Meyer & Co. Ltd.
Sontec Instruments, Inc.,
Rumex International Co.,
American Ophthalmic Laboratories, LLC.,
more...
The ultra-microtome diamond knife is a cutting instrument having sharp and stable edge that allows slices of tissues or to cut various other materials. Diamonds for microtome knives are selected from gem-quality crystals free of inclusions and internal flaws, which could interfere with the formation of a perfect edge.
Oasis Medical, Inc.,
Rhein Medical Inc.,
Jencons Scientific Inc.,
more...
(FDA Code:
LYL /
886.5928)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
Classification. Class II (Special Controls) Guidance Document: "Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products."
Ciba Vision,
Lifestyle Company, Inc. The,
Bausch & Lomb,
more...
Ultrasonic pachymetry is an efficient and accurate way to measure corneal thickness. It is the recommended method for obtaining corneal thickness measurements. It possesses the advantages of reproducibility, ability to take measurements anywhere on the cornea, not dependent on patient fixation, high accuracy and ability to be used intraoperatively.
Nidek Inc.,
Quantel Medical, Inc.,
Sonomed, Inc.,
more...
Ultrasonic phacoemulsification system consists of an ultrasonic phacoemulsification handpiece and a handpiece driver. The aspiration component of a phacoemulsification system removes lens fragments and fluids from the anterior chamber. The phacoemulsification handpiece generates ultrasonic energy that fragments the lens material into small pieces that can be aspirated from the capsular bag and anterior chamber. It is light, durable and requires less power, and has an extremely high speed frequency.
Pro Orthopedic Devices,
Allergan, Inc,
American Optisurgical Inc.,
more...
Kashika Enterprise,
Brytech Inc.
Unidirectional occluder is ideal for visualizing dissociated vertical deviation. It is suitable for use in the detection and identification of various misalignment conditions of the eye.
MedexSupply,
Welch Allyn, Inc.
Pro Orthopedic Devices,
DENOVO Dental Inc.,
Masel,
more...
Ambu Inc
Ambu Inc,
AAKK Surgical Corporation
Pro Orthopedic Devices,
DENOVO Dental Inc.,
Masel,
more...
FCI Ophthalmics
American Optisurgical Inc.,
Bovie Medical Corporation
Pro Orthopedic Devices,
DENOVO Dental Inc.,
Masel,
more...
Sontec Instruments, Inc.,
Elmed Inc.,
Zimmer, Inc.,
more...
Precision Vision, Ltd.,
GAM Laser, Inc.,
Haag-streit USA Inc,
more...
Sontec Instruments, Inc.,
A1 Medical Sales,
World Precision Instruments, Inc.,
more...
Pro Orthopedic Devices,
DENOVO Dental Inc.,
Masel,
more...
Vectographic Slides are used for many years to test for monocular acuity under binocular conditions, axis of astigmatism of each eye under binocular conditions, acuity & accommodative balance between the right and left eyes, binocular instability, parity between monocular & binocular acuity, muscle balance, fixation disparity and stereo acuity. Vectographic slides provide the ability to conduct a wide variety of tests for both children and adults including astigmatic tests, acuity tests, muscle balance tests and stereopsis tests.
Stereo Optical Co., Inc.,
Vision Assessment Corp.
Stereo Optical Co., Inc.
MedPACS Display, Inc.
Richmond Products, Inc.,
Akriti Oculoplasty Logistics
Stereo Optical Co., Inc.
Vertical Microscissors are used for peeling and cutting fine epiretinal membranes. It features rounded lower edge scissors blade, which minimizes unintentional engagement of retina.
Medone Surgical, Inc.,
Dutch Ophthalmic USA,
Robbins Instruments, Inc.,
more...
Carl Zeiss Meditec, Inc.,
ImagingPlanet,
TTI Medical,
more...
Video magnification systems can help improve quality of life for the visually impaired by dramatically enlarging printed text or photographs. It uses a video camera to project a magnified image of printed text, handwriting and photographs onto a video monitor, PC or TV screen.
Enhanced Vision,
Eschenbach Optik of America Inc.,
The Low Vision Center Of Indianapolis,
more...
Vrmagic GmbH
(FDA Code:
LZP /
886.4275)
Identification. An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
Classification. Class III.
Oasis Medical, Inc.,
Allergan, Inc,
Staar Surgical Company,
more...
Oasis Medical, Inc.,
Staar Surgical Company,
Abbott Medical Optics, Inc.,
more...
Vision databases can be displayed from the press of a button on the screen. Data can be automatically sorted either by the date and time of photography or by patient name or donor cornea number. Changes can be made as desired. It allows images, analytical results, and eyebank or clinical information to be stored in an easy-to-access database.
Bio-optics,
Datacube Inc.
(FDA Code:
HOT /
886.591)
Identification. An image intensification vision aid is a battery-powered device intended for use by a patient who has limited dark adaptation or impaired vision to amplify ambient light.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
Eschenbach Optik of America Inc.,
Keeler Instruments Inc.,
CTP Coil Inc.,
more...
Vision tester is an instrument used to test certain visual functions of near and far viewing distances. It encompasses a slide projector for projecting a visual indication chart onto a curved display screen through a mirror rotated by a motor. The center of curvature of the curved display screen substantially coincides with the subject's eye. The rotation of the mirror causes an image of the visual indicator to be moved across the screen in a specific direction. When the subject provides a response to the moving image, the speed of image movement at the time of the response is detected and stored in a memory. The average of a plurality of such measurements is used to determine the subject's dynamic visual acuity.
Ophthalmic Instruments, Inc.,
Specialty Automated Systems,
Depisteo,
more...
Pro Orthopedic Devices,
Richmond Products, Inc.,
Rolex Surg-icon Incorporation
Stereo Optical Co., Inc.,
Vision Assessment Corp.
Oasis Medical, Inc.,
Precision Vision, Ltd.,
AMA Optics, Inc.,
more...
Oasis Medical, Inc.,
Specialty Automated Systems,
AMA Optics, Inc.,
more...
Vision testing, Screenoscopes provide fast, accurate, and reliable tests of a wide variety of visual performances. This optical system duplicates conditions for viewing far point test charts at 5 meters (16') and provides conditions for near point test charts at 30cm (12″).
Neitz Instruments Co., Ltd.
Oasis Medical, Inc.,
Specialty Automated Systems,
LKC Technologies, Inc.,
more...
Oasis Medical, Inc.,
MedPACS Display, Inc.,
Akriti Oculoplasty Logistics
(FDA Code:
HOX /
886.115)
Identification. A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
Oasis Medical, Inc.,
Precision Vision, Ltd.,
Marco,
more...
Visual acuity systems have Dr. Hermann Snellen's original chart on the exam room wall. These systems have remote controls and bright displays. This allows the clinician to be at the patient's side to fine tune the refraction, while keeping the room lighting dim yet comfortable.
Oasis Medical, Inc.,
Specialty Automated Systems,
LKC Technologies, Inc.,
more...
A visual evoked potential is an evoked potential caused by sensory stimulation of a subject's visual field and is observed using an electroencephalography. It is very useful in detecting blindness in patients that cannot communicate, such as babies or non-human animals. Commonly used visual stimuli are flashing lights, or checkerboards on a video screen that flicker between black on white to white on black (invert contrast).
Oasis Medical, Inc.,
LKC Technologies, Inc.,
Diagnosys, LLC,
more...