Carl Zeiss Meditec, Inc.,
Allergan, Inc,
Iridex Corporation,
more...
The slit lamp is the primary instrument used in evaluating the cornea. The ophthalmologist chooses between eight and forty-power magnification for examining all levels of the cornea with a narrow beam of collimated light. It consists of a high-intensity light source that can be focused to shine as a slit. It is used in conjunction with a microscope. The lamp facilitates an examination, which looks at anterior segment, or frontal structures, of the human eye, which includes the eyelid, sclera, conjunctiva, iris, natural crystalline lens, and cornea.
Superior Medical Systems, Inc.,
Carl Zeiss Meditec, Inc.,
Allergan, Inc,
more...
Nidek Inc.,
Visx USA, Inc.,
GAM Laser, Inc.,
more...
Small eyelid implant is a small gold plate shaped to fit eye. It is thin, with smooth, tapered edges designed to make it fairly inconspicuous when it is implanted into eyelid. The weight of the implant is precisely calibrated to allow gravity to pull eyelid closed when relax the muscle that lifts upper eyelid. When tense the muscle again, the eyelid opens normally. Gold is the ideal material for these implants because gold does not corrode, it is heavy and it is virtually inert, making it very unlikely to irritate the tissues in eyelid.
FCI Ophthalmics
Sodium chloride - Ophthalmic solution is used to reduce swelling of the cornea in certain eye conditions. It can offer effective temporary relief when the person suffers from corneal edema.
Eye Technology Ltd.
Smaller punctum plugs are effective in treating moderate to severe dry eye that is unresponsive to artificial teardrops and ointments. It increases the comfort level and lowers the frequency of artificial tear use in most dry eye patients. It can be inserted either in the lower eyelid or in the upper eyelid or in both eyelids. These plugs are smaller in size.
Oasis Medical, Inc.,
FCI Ophthalmics,
Eagle Vision,
more...
Saber Medical Inc.,
Ev3, Inc.,
LSVP International, Inc.,
more...
A snellen chart is an eye chart used by eye care professionals and others to measure visual acuity. It is generally printed with eleven lines of block letters. The first line consists of one very large letter. Subsequent rows have increasing numbers of letters and decreasing in size. A patient taking the test covers one eye, and reads the letters of each row, beginning at the top. The smallest row that can be read accurately indicates the patient's visual acuity in that eye.
Alimed, Inc.,
Visionscience Software,
Narang Medical Limited,
more...
The Snellen eye chart has a series of letters or letters and numbers, with the largest at the top. As the person being tested reads down the chart, the letters gradually become smaller. It is used to test visual acuity, position the patient 10 or 20 feet in front of the Snellen eye chart.
Alimed, Inc.,
Zhejiang Regent Medical Technology Co., Ltd,
Hae Sung Medical Co.,
more...
Biosource International,
Teknova, Inc.
Biosource International,
Invitrogen Corporation,
Teknova, Inc.,
more...
Soft contact lens storage solutions offer two kinds of moisturizers, essential electrolytes and taurine. It cleans, rinses, disinfects, and removes protein. It can store and condition any soft contact lens, including conventional and silicone hydrogel lenses.
Abbott Medical Optics, Inc.,
Ciba Vision,
Bausch & Lomb
Soft contact lens rinsing solutions provide the protection of hydrogen peroxide for patients. It cleans accumulate protein and other hard-to-remove deposits, which interfere with wearing comfort and clear vision.
Abbott Medical Optics, Inc.,
Ciba Vision,
Bausch & Lomb
Extended wear contact lenses are a type of contact lens that attempts to deliver the convenience of being able to see without eyeglasses all of the time. Extended wear contact lenses soft lenses are made from highly oxygen permeable hydrophilic polymeric materials. These lenses allow more oxygen to pass through to the cornea.
Precision Vision, Ltd.,
World Wide Medical,
Bausch & Lomb,
more...
(FDA Code:
LPN /
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."
Allergan, Inc,
Lobob Laboratories, Inc.,
Abbott Medical Optics, Inc.,
more...
Mastercraft Dental Co. Of Texas,
Ortho Class,
Monitex Industrial Co., Ltd.,
more...
Sopamycetin ophthalmic ointment is a trade name for chloramphenicol, an antibiotic that binds to 5OS ribosomal sub units, inhibiting bacterial protein synthesis. It is used to treat infections of the eye.
Akorn, Inc.
SBH Surgical,
Saber Medical Inc.,
Medtronic Ophthalmics,
more...
(FDA Code:
NJH /
886.5844)
Identification. A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.
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.
Malagar LLC,
Advanced Digital Eyewear,
Signet Armorlite, Inc.,
more...
(FDA Code:
HQZ /
886.5842)
Identification. A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.
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.
General Scientific Corporation,
SIGMA-ALDRICH CORP,
Mancine Optical Inc.,
more...
Spectacle indirect ophthalmoscope is ideal for office, hospital, and nursing home visits. It gives ophthalmologist a true stereopsis in small pupil exams from 2mm and up. Its leading edge design assures the ultimate in clarity (with illumination and image). It accommodates practitioners with smaller interpupillary distances, generally 49 to 74 mm.
Pro Orthopedic Devices,
Welch Allyn, Inc.,
Carl Zeiss, Inc.,
more...
Spectral transmittance meter is an electric equipment designed to measure light wavelength transmission in all types of lens material. It provides an easy way for the user to understand the differences between multi-coated and UV protected sunglasses. It enables determinations of UV transmission as well as visible light wavelength.
Topcon America Corporation
(FDA Code:
NQE /
886.185)
Identification. 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.
Classification. Class II.
Veatch Ophthalmic Instruments,
HAI Laboratories, Inc.,
Topcon America Corporation,
more...
Carl Zeiss Meditec, Inc.,
Topcon America Corporation,
Accu-Scope Inc.,
more...
(FDA Code:
HNP /
886.435)
Identification. 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.
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.
Bio-eye Orbital Implants,
Sontec Instruments, Inc.,
Vyaire Medical, Inc.,
more...
ABBA Optical, Inc,
United Contact Lens, Inc.,
SiChuan JUKA Optical Technology,
more...
Bausch & Lomb,
Fishgillz Sunglass Co.,
Unique Sports Products, Inc.,
more...
A spot retinoscope is a hand-held instrument that is used to objectively determine the refractive power of the eye. A spot of light is reflected off of a front surface mirror. This light is emitted from the instrument and the spot type can be rotated 360 degrees.
Ophthalmic Instruments, Inc.,
Welch Allyn, Inc.
Oasis Medical, Inc.,
Unique Technologies, Inc.
Stab incision blades are designed for stab incisions. It is usually color coded for simple and accurate identification.
Stradis Healthcare, LLC,
George Tiemann & Co.,
Unique Technologies, Inc.
Rusch Inc.,
Autosuture,
High Class Dental,
more...
Howard Instruments, Inc.,
Pro Orthopedic Devices,
TDI International, Inc.,
more...
Stainless steel jaeger lid plates effectively protect the cornea and globe during eyelid procedures. It is made of stainless steel material. It provides ultimate protection during electrosurgical techniques.
Byron Medical, Inc.,
Marina Medical Instruments Inc.,
Anthony Products, Inc.,
more...
Stainless steel mayo scissors are made of stainless steel materials. It is ideal for cutting heavy fascia and sutures. It is designed for right- or left-handed use. It is available in many styles, and sizes.
Pro Orthopedic Devices,
TDI International, Inc.,
DENOVO Dental Inc.,
more...
Stainless steel mayo stand is constructed of non-corrosive stainless steel material. It is designed for convenience during surgical procedures. It consists of U-shaped base that minimizes interference with other equipment or patient, removable stainless steel tray, two rubber wheel, and ball bearing casters.
Galaxy Salon Furniture & Equipment,
MedexSupply,
CM X-Ray Enterprise,
more...
AZReam, Inc.,
Stradis Healthcare, LLC,
George Tiemann & Co.,
more...
Lambda retinometer is a device used for assessing potential visual acuity of patients with cataracts and other opacities. It scans the pupil with the red light spot to find a window through which the patient can recognize the grating pattern and identify its angle.
Richmond Products, Inc.,
Akriti Oculoplasty Logistics
Stand magnifiers incorporate a high-power magnifying lens in a housing that presets the lens at the appropriate focal distance for its strength, without the user having to maintain the working distance or hold it steady. It is a very useful option, when a person has difficulty holding a hand magnifier steady. These magnifiers stand flat on the page and the user slides it along while looking straight down through the lens. It is also available with and without self-contained illumination and may be either battery-powered or plug-in.
Eschenbach Optik of America Inc.,
Electro-Optix, Inc.,
Anchor Optical Surplus,
more...
Pro Orthopedic Devices,
Cambrian Medical Inc.,
Optos North America,
more...
AZReam, Inc.,
Merit Pharmaceutical, Inc.,
Medzer Inc,
more...
The standard ophthalmoscope uses halogen light for true tissue color and consistent, long-lasting illumination. It is versatile and reliable for general use. It has halogen light for true tissue color and consistent, long-lasting illumination.
AZReam, Inc.,
Medisave USA LLP,
Tekyard LLC,
more...
Synemed,
Carl Zeiss Meditec, Inc.,
Nidek Inc.,
more...
(FDA Code:
HLC /
886.146)
Identification. A stereopsis measuring instrument is a device intended to measure depth perception by illumination of objects placed on different planes.
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.
Bernell VTP,
Eye Care and Cure,
Astron International Inc.,
more...
Stereoscopic vision and depth perception testing is performed to diagnose stereo and binocular vision in children and adults. The test can be used for testing and training of binocularity, stereopsis, visual attention, and depth perception.
Stereo Optical Co., Inc.,
Richmond Products, Inc.
Sterile irrigating solution exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues, wounds, indwelling urethral catheters, and surgical drainage tubes. It is used for washing and rinsing purposes that allow use of a sterile nonpyrogenic electrolyte solution.
Pro Orthopedic Devices,
Cytosol Ophthalmics, Inc.,
C Change Surgical LLC
Sterile marking pens are used on individual patients to minimize the risks of cross-infection. It provides non-toxic ink for marking on the skin. Ink remains visible after surgical preparations swabs.
Qsum Biopsy Disposables LLC,
Op-Marks, Inc.,
Ioltech Laboratories
Stradis Healthcare, LLC,
George Tiemann & Co.,
Specialty Blades, Inc.
Sterile occluders are indicated for the treatment of dry eye syndrome. It is designed to provide a simple, reversible means of long term punctal occlusion by reducing or eliminating tear drainage via the punctum. The occluder is easy to insert and comfortable for the patient after placement.
Richmond Products, Inc.,
Daiken Medical Co., Ltd.
Sterile ophthalmic ointment is a sterile antimicrobial ointment formulated for ophthalmic use. This medication attacks gram-negative bacilli, including virtually all strains of pseudomonas aeruginosa and haemophilus influenzae species.
Akorn, Inc.,
Bausch & Lomb
A sterile eyelid speculum is used to hold the eyelid open. The injection is administered into the back and side of the eyeball by a syringe with a 27 gauge or 30 gauge needle.
Medtronic Ophthalmics,
Surgical Specialties Corporation
