Search Results
Found 2279 results
510(k) Data Aggregation
(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.
N/A
Ask a specific question about this device
(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.
N/A
Ask a specific question about this device
(239 days)
Ask a specific question about this device
(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.
N/A
Ask a specific question about this device
(150 days)
Ask a specific question about this device
(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.
N/A
Ask a specific question about this device
(160 days)
-
Sphere and Asphere
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Sphere and Asphere designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. -
Toric
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.50 to -3.50 diopters. -
Multifocal
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
The lenses are intended for single-use disposable wear.
The Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses are visibility-tinted and include UV blocker-containing materials. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tinted with "Reactive Blue 19", "Reactive Red 180", and "Reactive Yellow 15", which are approved color additives by the U.S. FDA and listed in 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).
N/A
Ask a specific question about this device
(35 days)
The ACCUJECT IOL Injector is indicated to fold and insert BVI IOLs approved for use with this injector in the human eye.
The ACCUJECT Injector Set is an assembled injection system that is single use with a silicone cushion tip that is used to push forward and insert the IOL that has been placed in a single use cartridge into the eye. As the lens enters the tip it is folded and compressed.
N/A
Ask a specific question about this device
(135 days)
XTRA4 is a corneal storage solution for storage of human cornea suitable for keratoplasty for up to 14 days under refrigeration (2-8°C).
XTRA4 (ref. EXT4 001-01) is a sterile hypothermic corneal storage medium intended for human corneal storage between 2 and 8°C for up to 14 days. It is designed as a single use 20 mL solution in glass vials. XTRA4 is intended to be used only by physicians or highly skilled personnel such as eye bank operators. The preservation of donor cornea is traditionally performed by storing them at temperatures between 2°C and 8°C in a storage medium containing deswelling agent(s).
N/A
Ask a specific question about this device
(111 days)
Sphere and Asphere:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the spherical and aspheric design are indicated for monthly disposable wear for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Toric:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the toric design is indicated for monthly disposable wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
Multifocal:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the multifocal design is indicated for monthly disposable wear for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each month, or more often, if recommended by the eye care professional.
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is a hemispherical shell with a molded base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lens is fabricated from somofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 44.0% somofilcon A and 56.0% water by weight when immersed in saline solution. The somofilcon A name has been adopted by the United States Adopted Names Council (USAN).
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens contains phthalocyanine blue (21 CFR Part 74.3045) for visibility and handling. The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >80% in the UVA range (316nm - 380nm).
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is manufactured in spherical/aspheric, toric, multifocal design configurations. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance |
|---|---|---|
| Chord Diameter | 11.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.050 mm to 0.200 mm | When ≤ 0.10 mm ±0.010 mm + 10% When > 0.10 mm ±0.015 mm + 5% |
| Base Curve | 7.0 mm to 10.0 mm | ±0.20 mm |
| Back Vertex Power (F'v) | -20.00 D to +20.00 D (in 0.25 D steps) | When 0.00 < |
| Cylinder Power (F'c) | -0.25 D to -2.25 D (in 0.25 D steps) | When 0.00 < F'c ≤ 2.00 D ±0.25 D When 2.00 < F'c ≤4.00 D±0.37 D |
| Cylinder Axis | 10° to 180° in 10° steps (in 10° steps) | When 0.00 < F'c ≤ 1.50 D ± 8° When F'c > 1.50 D± 5° |
| Multifocal Power | +0.25 D to +4.00 D (in 0.25 D steps) | ±0.25D |
| Oxygen Permeability (x 10-11 (cm2•ml O2)/(sec•ml•mmHg)) | 60 | ±20% |
| Visible Light Transmittance | >95% | ±5% |
| Ultraviolet radiation Transmittance | < 5% TUVB <20% TUVA | TUVB (280 to 315nm) < 0.05 TV TUVA (316 to 380nm) < 0.05 TV |
| Water Content | 56% | ±2% |
| Refractive Index | 1.398 | ±0.005 |
N/A
Ask a specific question about this device
Page 1 of 228