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510(k) Data Aggregation
(119 days)
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(58 days)
DAILIES TOTAL1® (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES TOTAL1® Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
The lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
DAILIES TOTAL1® (sphere) and DAILIES TOTAL1® Multifocal are soft contact lenses made from delefilcon A lens material. Delefilcon A is a silicone hydrogel material with a water content of approximately 33% and a water gradient surface treatment. The lenses have a light blue tint that makes them easier to see when handling. When hydrated and placed on the cornea, DAILIES TOTAL1® (delefilcon A) soft contact lenses act as a refracting medium to focus light rays on the retina.
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(214 days)
The LANDR Contact Lens Case is designed for storing soft (hydrophilic), rigid gas-permeable, and/or rigid contact lenses. It is only for use during storage with chemical disinfection and should not be used during heat disinfection.
The LANDR Lens Case has dual-sided storage compartments (one per lens) stacked together (Figure 1). The case uses a ball plunger to hold the detachable cases together in one piece during shipping. Each compartment is colored to differentiate the cases.
The individual cases should be separated by pulling them apart and placing them on a flat surface right side up before use (Figure 2). When disinfecting and storing contact lenses, each case must be kept upright on a flat surface in the correct orientation (Figure 2) with the lids securely closed.
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(266 days)
The INTEGRE LIO is indicated to be used in ophthalmic laser procedures including retinal photocoagulation.
The INTEGRE LIO is a laser photocoagulator using visible green diode laser (532nm) technology and provide a compact design to be incorporated in a lightweight headset worn by the physician.
The INTEGRE LIO is composed of:
- a battery powered headset based on an indirect ophthalmoscope including a laser enclosure and a Head-Up Display (HUD)
- a wireless battery powered footswitch.
INTEGRE LIO is controlled by the wireless footswitch that allows the physician to set the desired parameters for treatment. The physician uses the headset to locate the area to be treated and, after setting the appropriate parameters, targets the desired tissue utilizing a visible red aiming beam. The physician presses the footswitch to deliver therapeutic green laser light to the targeted tissue. In case the battery is discharged, and the user needs to continue treatment, there is a cable available that connects the footswitch to the headset and an external power supply to connects the footswitch to an electrical outlet.
The INTEGRE LIO includes laser safety filters that will prevent a laser beam reflection to user's eye. The laser unit must be used with a focusing lens which allows retinal visualization.
Ancillary personnel must wear appropriate laser safety eyewear to protect their eyes from laser beam
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(261 days)
The Eyer 2 is accompanied by accessories: frontal module for the ocular surface (1pc), dock station (charging station) (1pc), eye cap (1pc), lens protector (1 pc), storage case (1 pc), cleaning cloth (1 pc), allen wrench (1 pc), quick start guide (1 pc), welcome card (1 pc), shipping box (1 pc), power supply (1 pc), slit-lamp adapter (1 pc), silica gel bags (2 pcs).
Eyer 2 is designed for use in a medical environment by healthcare professionals. Captured images and videos are used for documentation and consultation. The images and videos are securely stored in an internal smartphone application database.
For the retinal function, the Eyer 2 is designed for non-mydriatic fundus imaging. In non-mydriatic imaging, no mydriasis is needed because infrared light is used for targeting the fundus and white light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. Eyer 2 has fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-center image. It is possible to fix the optical disc in the center by selecting the appropriate point.
For the ocular surface and surrounding areas function, Eyer 2 has an ocular surface module with white, blue, and infrared light sources for imaging the eye surface and surrounding areas; in this configuration, the device does not make contact with the patient.
The transfer of images to a PC is carried out via DICOM, DICOMWEB, FTPS, or local folder connections, with the client responsible for the connection and subsequent storage.
The Eyer 2 energy comes from the smartphone that has a rechargeable Li-Ion battery and is charged when the device is docked on the charge station, which is connected to the mains by a power supply cable.
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