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510(k) Data Aggregation

    K Number
    K251507

    Validate with FDA (Live)

    Device Name
    INTEGRE LIO
    Manufacturer
    Date Cleared
    2026-02-06

    (266 days)

    Product Code
    Regulation Number
    886.4390
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K251353

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    Device Name
    Eyer 2
    Date Cleared
    2026-01-16

    (261 days)

    Product Code
    Regulation Number
    886.1120
    Age Range
    N/A
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description

    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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    K Number
    K252633

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    Device Name
    UNITY DX (UDX)
    Manufacturer
    Date Cleared
    2025-12-23

    (125 days)

    Product Code
    Regulation Number
    886.1570
    Age Range
    22 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Unity DX instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of anterior and posterior ocular structures and measurement of anterior segment and biometric parameters including:

    • Axial Length
    • Anterior Chamber Depth
    • Central Corneal Thickness
    • Lens Thickness

    The Reference Image functionality is intended for use as an ocular image capture tool.

    Device Description

    The UNITY DX instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of anterior and posterior ocular structures and measurement of anterior segment and biometric parameters including axial length, anterior chamber depth, corneal thickness, lens thickness, and reference image. The UNITY DX device has four (4) measurement modalities: HP-OCT, wavefront measurement, reference image, and reflective topography.

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    K Number
    K251683

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    Date Cleared
    2025-12-23

    (207 days)

    Product Code
    Regulation Number
    886.5925
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in presbyopic phakic and aphakic persons with non-diseased eyes who exhibit 1.00D or less of astigmatism that does not interfere with visual acuity. The lens mitigates the effects of presbyopia by providing an Extended Depth of Focus (EDOF).

    Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) is to be prescribed for single-use disposable wear and are to be discarded after each removal.

    Device Description

    Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) lens material, vifilcon C is a hydrophilic polymer of 2-hydroxyethyl methacrylate, methacrylic acid and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA) and using azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H- Benzotriazol-2yl)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The lens contains 60% water by weight in a saline solution containing hyaluronic acid and TSP (Tamarind Seed Polysaccharide) polymers. The lens is visibility tinted using Pigment Blue 15 (Copper phthalocyanine) to make the lens more visible for handling.

    The anterior surface of the contact lens is designed with a spherical geometry across the optical zone. The lens includes a centrally located zone with a diameter of 1.0 mm and a dome-shaped profile. This central zone allows the transmission of light but is not intended to focus light to produce distinct retinal images. The curvature of the central zone is steeper than that of the surrounding optical power zone and is designed to provide a power difference relative to the base spherical power of at least +6.00 diopters. The central, functional optically inactive zone is intended to increase the depth of focus for the wearer.

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    K Number
    K252348

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-18

    (142 days)

    Product Code
    Regulation Number
    886.1850
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OA-2000 is a non-invasive, non-contact biometer intended for obtaining ocular measurements to assist in the determination of the appropriate power of an intraocular lens for implantation. The OA-2000 measures: Axial length, corneal thickness, anterior chamber depth and lens thickness.

    Device Description

    The Tomey OA-2000 ophthalmic optical coherence biometer is an ophthalmology device used to measure the length of living tissue utilizing light interference technology and to measure the corneal shape on captured images. This device is designed to measure axial length, anterior chamber depth, corneal thickness, crystalline lens thickness, and corneal shape.

    The instrument contains an internal database and has various IOL power formulae applicable to ordinary cataract surgery and/or cataract surgery of eyes with corrected corneal refractive power and provides data necessary to assist the physician in determining IOL power.

    The OA-2000 biometer is equipped with a 10.4-inch large touch-screen monitor for ease of use and includes Auto Alignment and Auto Shot functions. Manual measurement is also available in the event that automatic measurement is difficult.

    Fourier-domain optical biometry is a high-resolution, non-invasive optical measurement technique based on the principle of low-coherence interference. It is used to determine the distance or depth of reflective structures. Fourier-domain optical biometry is based on the principle of low-coherence interferometry. A low-coherence light source is split into two beams: one directed toward a reference mirror, and the other toward the patient's eye. Light reflected from both the reference and sample arms is combined to produce an interference pattern, but only if the optical path lengths of the two arms are closely matched. This interference signal indicates the location of reflective structures in the sample and is used to reconstruct depth-resolved images or measurements.

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    K Number
    K252120

    Validate with FDA (Live)

    Date Cleared
    2025-12-12

    (158 days)

    Product Code
    Regulation Number
    886.1120
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FOP NM-10 is an ophthalmic non-mydriatic digital camera using iPhone SE3 which captures images of the fundus of the human eye and surface as well as surrounding areas of the human eye.

    Device Description

    The FOP NM-10 is designed for imaging of the fundus and surface as well as surrounding area of the human eye, in a compact, portable format, with an inherent simplicity built in its operation and use. The application software (Remidio FOP) is loaded on top of the iOS operating system to enable the user to view, save, archive and retrieve the captured images of fundus and surface area of the human eye. It is a compact, battery-operated device that enables high-quality fundus photography without requiring pupil dilation. The device can be used in Hospitals and Ophthalmic clinics. The FOP NM-10 incorporates a 40° field of view (FOV) optical system optimized for high-resolution retinal imaging. The device employs infrared and white LED illumination to achieve adequate retinal illumination without causing discomfort to the patient. The device is built on a modular smartphone-based design, ensuring portability and ease of operation. The Remidio FOP app enables wireless control of illumination intensity, focus adjustments, capturing the images in Auto and manual modes, saving, editing and archiving images.

    Physical Specifications

    • a) Field of View: 40° (for a minimum pupil size of 3mm)
    • b) Material: ABS, Silicone Rubber
    • c) Diopter Correction: -16D to +16D
    • d) Working Distance: 33mm

    Output and Performance Characteristics

    • a) Illumination (Light Source): Infrared LED and Cool White LED
    • b) Camera Resolution: 64 line pairs per millimeter (lp/mm) (at the center)
    • c) ISO Range: ISO 200 and 400
    • d) Focus Adjustment: Manual and Tap to Focus
    • e) Internal Fixation: 8 fixation points
    • f) Operating temperature: 10° to 40°C
    • g) Relative Humidity: 10% to 85%
    • h) Atmospheric Pressure: 750 to 1060 hpa
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    K Number
    K250501

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    Device Name
    System Sophi
    Manufacturer
    Date Cleared
    2025-11-14

    (267 days)

    Product Code
    Regulation Number
    886.4670
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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).

    Device Description

    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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    K Number
    K253039

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    Manufacturer
    Date Cleared
    2025-11-07

    (46 days)

    Product Code
    Regulation Number
    886.1930
    Age Range
    2 - 65
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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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    K Number
    K251772

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    Manufacturer
    Date Cleared
    2025-10-29

    (141 days)

    Product Code
    Regulation Number
    886.4390
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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
    Device Description

    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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    K Number
    K251876

    Validate with FDA (Live)

    Date Cleared
    2025-10-09

    (113 days)

    Product Code
    Regulation Number
    886.5918
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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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