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510(k) Data Aggregation
(142 days)
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(158 days)
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(267 days)
The System Sophi is an integrated phacoemulsification lens removal device designed for use in intraocular ophthalmic surgery in the anterior chamber. System Sophi is intended for liquid irrigation and aspiration, lens fragmentation and ultrasonic phacoemulsification, anterior vitrectomy, and bipolar diathermy (high frequency surgical equipment).
The System Sophi is an integrated phacoemulsification lens removal device designed for use in intraocular ophthalmic surgery in the anterior chamber. System Sophi is intended for lens fragmentation and ultrasonic phacoemulsification, liquid irrigation and aspiration, anterior vitrectomy, and bipolar diathermy (high frequency surgical equipment).
A cassette is the interface between the System Sophi device and the surgical handpiece. It is used to regulate the balanced saline solution (BSS) irrigating fluid to the handpiece, to aspirate lens fragments and liquids from the handpiece, to monitor irrigation and aspiration flow and pressure and deposition of lens fragments and fluid into the waste bag for disposal. The cassette ports and tube connectors are coded to ensure proper connections at any time.
The system is controlled with a foot pedal (surgeon) and a graphical user interface (assistant). System Sophi is powered by mains voltage (AC-powered) or through a battery.
Only company-validated and recommended disposable sterile equipment and designated instruments and hand pieces are allowed.
The Sophi system is offered in three configurations: Sophi Premium, Sophi Eco and Sophi A, differing in the included options and accessories.
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(46 days)
TRK-3 OMNIA is a combination of the non-contact tonometer and pachymeter. The device is indicated for automatic measurement of intraocular pressure without contacting the eye (with less than 3 diopters of corneal astigmatism); and measurement of central corneal thickness.
TRK-3 OMNIA is a multiple function device, a combination of the auto refractometer, keratometer, non-contact tonometer, and pachymeter. The device is capable of automatic measurement of the refractive errors of the eye; measurement of the corneal curvature of the eye; measurement of intraocular pressure without contacting the eye (with less than 3 diopters of corneal astigmatism); and measurement of central corneal thickness. The device also calculates corneal diameter and pupil distance.
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(141 days)
The Navilas® Laser System is an ophthalmic laser integrated with a digital camera. The Navilas® Laser System is indicated for the treatment of ocular pathology in the anterior and posterior segment of the eye, with supporting imaging functions (capture, display, storage and annotation) of the retina of the eye via color and infrared imaging.
The Navilas® Laser System is intended for use in the posterior segment to perform Retinal Photocoagulation, Panretinal photocoagulation, focal photocoagulation or grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
- Proliferative and non-proliferative diabetic retinopathy
- Macular edema
- Choroidal neovascularization associated with wet age-related macular degeneration
- Age-related macular degeneration
- Central and branch retinal vein occlusion
- Lattice degeneration
- Retinal tears and detachments
Intended for use in the treatment of ocular pathology in the anterior segment including:
- Iridotomy
- Iridoplasty
- Trabeculoplasty
The Navilas Laser System 577SL is a laser photocoagulator with an integrated digital fundus camera. The Navilas Laser System 577SL combines imaging technologies (color and infra-red imaging) with established laser photocoagulation treatment methods by providing the physician a system for imaging and treatment planning prior to the photocoagulation procedure.
The Navilas Laser System 577SL is comprised of:
- A semiconductor laser source that operates at 577nm wavelength. The laser can operate with Continuous Wave (CW) or Micro-Second Pulsing (MSP).
- An integrated delivery system that directs the laser beam through an ophthalmoscope using motorized mirrors.
- A digital camera that provides continuous real-time imaging in color with white light illumination of the fundus, or in monochrome using infrared illumination.
- A software platform that is based on an embedded Windows operating system, that controls the startup, use, calibration, monitoring, and shutdown of the system.
The Navilas Laser System 577SL supports the user during multiple steps of a laser treatment procedure with digital imaging, image storage, planning and laser treatment options including:
Digital imaging - Provided by a color image with white light, supporting mydriatic and nonmydriatic image acquisition (with and without dilated pupils), or a monochrome IR image. Images are presented using a digital display. An illumination mode is selected where images are acquired and either stored, exported or discarded after viewing on the touch sensitive digital display.
Image Storage - Captured images can be digitally stored in the Navilas Laser System 577SL database along with other patient related data to create a complete patient record for future reference. Images from other devices may also be imported and stored.
Planning - Areas identified on acquired or imported images by the user that are selected for future treatment consideration can be marked through the use of treatment planning tools available. The physician has the ability to highlight areas on acquired images (called Points of Interest). These locations are created and manipulated using the touch sensitive digital display.
Laser Treatment - Treatment options are also unchanged from the predicate device with Pre-planned and Ad-hoc Modes available on all Navilas laser models. Pre-positioning of the aiming beam onto locations which are selected by the physician during planning is also facilitated. The position of the aiming beam can be monitored on the real-time image that is displayed on the touch sensitive digital display.
Report generation - Information collected in the database includes images obtained before, during and after treatment. This information can be used for the generation of patient reports for documentation purposes.
The Navilas Laser System 577SL can emit a 577 nm wavelength beam for photocoagulation with power up to 1700 mW and pulse duration up to 4000 ms.
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(113 days)
cleadew GP hydra one is indicated for cleaning, removing protein, rinsing, disinfecting, conditioning, and storing fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.
Ophtecs cleadew GP hydra one is a sterile, aqueous, buffered solution that contains Boric acid, Disodium Phosphate, Trometamol, Glutamic Acid, Sodium Chloride, Polyoxyethylene 9 Lauryl Ether, Tetrasodium (1-hydroxy-1,1-ethanediyl)bis(phosphonate), C12-13 Alkyl Glyceryl Hydrolyzed Hyaluronate, Sodium Hyaluronate and Hypromellose; preserved with Hydrogen peroxide (0.004%) and Polyhexamethylene biguanide hydrochloride (0.0005%). The solution is for cleaning, removing protein, rinsing, disinfecting, conditioning, and storing fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.
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(239 days)
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less does not interfere with visual acuity.
Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.
Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non- diseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multi-focal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.
Saview SH Optic 38 UV, Saview SH Optic 38 UV toric, and Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is daily disposable wear. Eye care practitioners may prescribe the lens for daily disposable wear. The lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.
The lens designs include spherical, toric and multifocal lenses.
UV absorbing monomer is used. The transmittance are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
Tinted blue [Phthalocyaninato(2-)] copper in color additives approved in 21 CFR Part 74 for use in medical device is used.
The lens contains 38% water by weight and each lens is supplied sterile in a blister container in saline solution with PEG.
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(273 days)
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear and Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens are indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professionals may prescribe the lens for single use daily disposable or reusable daily wear in a Frequent Replacement Program.
DISPOSABLE WEAR:
When prescribed for Disposable Wear, the Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens is to be discarded after each removal.
FREQUENT/PLANNED REPLACEMENT WEAR:
When prescribed for Frequent/Planned Replacement Wear, the Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear should be disinfected using a chemical or hydrogen peroxide disinfecting system each time it is removed and should be discarded per the eye care practitioner's guidance.
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear and Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens are hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Otufilcon A, which is a copolymer of silicone-containing monomers and hydrophilic monomers, and has 44% water by weight.
These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. Thus, the lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye. The transmittance characteristics are less than 5 % in the UVB range of 280 nm to 315 nm and less than 50 % in the UVA range of 315 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive. The lens is marked with wording "321" to help user better distinguish the correct side before inserting in eyes.
The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with A) PMB Packaging Solution, or B) Cyanocobalamin Packaging Solution depends on customer's requirement.
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(150 days)
The Essilor® Stellest® lens is indicated for the correction of myopia with and without astigmatism and for slowing the progression of myopia in children with non-diseased eyes, who, at the initiation of treatment, are aged 6-12 years and have spherical equivalent refraction of -0.75 D to - 4.50 D with astigmatism up to 1.50 D.
The Essilor® Stellest® is a prescription only (Rx only) device that is a pair of spectacle lenses fitted with the patient's refractive prescription. The unique features of this device are concentric rings of aspheric lenslets (small lenses) which focus portions of the incoming light in front of the retina, causing blur on the retina. The figure below shows a single lens where the 9mm diameter central zone is free from lenslets and 11 concentric lenslet rings are visible. Each ring has a slightly different focusing power. The device is designed to slow the elongation of the eye and a provide a reduction in the progression of myopia in myopic children.
The Essilor® Stellest® spectacle lenses are intended to be worn by a pediatric patient in a spectacle frame, as eyeglasses are worn. There is no specific frame that comes with the Essilor® Stellest® lenses. Rather, the Essilor® Stellest® lenses are mounted into a chosen spectacle frame, based on patient preference in conjunction with their healthcare provider or optician. The Essilor® Stellest® lenses are made from polycarbonate with Crizal® Easy Pro coating, an anti-reflectance coating, and are not tinted. Labeling for the Essilor® Stellest® device is provided to both the healthcare provider/optician and the pediatric patient/caregiver(s).
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(30 days)
The LenSx Laser system is indicated for use:
- In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
- In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
- In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.
The LenSx Laser system is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create vapor bubbles which disrupts/separates tissue (photodisruption) within the lens capsule, crystalline lens, and the cornea. A computer-guided delivery system places the laser pulses in a pattern to produce an incision/cut.
The laser pulses are delivered through a sterile, disposable applanating lens and suction ring that contacts the cornea and fixes the eye with respect to the laser delivery system.
The interface between the laser and patient is the Patient Interface that connects to the delivery system which is docked to the patient's cornea. Two models of the Patient Interface accessory are offered for use with the LenSx Laser: the LenSx Laser Patient Interface and the LenSx Laser SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly. The LenSx Laser SoftFit Patient Interface also comes with a soft contact lens that is positioned against the external surface of the Patient Interface glass. For cataract procedures, the LenSx Laser SoftFit Patient Interface is used. The LenSx Laser Patient Interface is used for corneal, flap, tunnel, and pocket incisions. Refer to the Instructions for Use supplied with the LenSx Laser Patient Interface for preparation and application.
The LenSx Laser system is for prescription use and should only be operated by a trained physician. The LenSx Laser system is intended to be used within a clinic(s)/hospital(s)/surgical practice network.
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