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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.

The ELITA™ Femtosecond Laser System is an ophthalmic femtosecond laser indicated in the creation of corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea. The ELITA™ Femtosecond Laser System is used in conjunction with a sterile disposable Patent Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use.

The ELITATM Femtosecond Laser System is an ophthalmic laser for corneal surgical operation. The system accurately cuts cornea tissue through a high pulse repetition rate and ultra-fast scanner to place pulses tightly next to each other, generating a continuous cutting surface. The system is controlled by the graphical user interface and software real-time controls. The optical delivery system determines a 3-dimensional position in the cornea at which the laser focuses. When the laser is emitted, the energy delivered is sufficient to photo-disrupt a small volume of tissue. The process of cutting involves repetitively setting a focus point and translating the laser cutting line generated by the resonant scanner. The ELITATM Femtosecond Laser System is a CDRH Class IV laser per 21 CFR 1040.10 and 1040.11 due to intentional laser exposure of the eye.

The CATALYS™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/ incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Catalys™ Precision Laser System ophthalmic surgical laser system Device Description: used in healthcare facilities such as hospitals. Ambulatory Surgerv Centers (ASCs) and surgeon office settings. The System is an electromedical device which contains software. System components include a single-use Liquid Optics™ Interface and optional Mobile Patient Bed. The Catalys™ Precision Laser System (also referred to as the Catalys™ System or System) is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the threedimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus). The Catalys™ Precision Laser System laser classification per 21 CFR 1040.10 and 1040.11 is Class 4.

The ALLY™ Adaptive Cataract Treatment System is an ophthalmic surgical laser indicated for use: - · in the creation of an anterior capsulotomy. - · in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens. - · in the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea.

The ALLY" Adaptive Cataract Treatment System (ALLY" System) is a medical device intended for use in ophthalmic surgery. The ALL Y™ System brings the precision of femtosecond laser to the cataract procedure. The ALL Y™ System allows for an initial femtosecond laser procedure using a dual-pulse-width laser used to cut a precision capsulotomy in the anterior lens capsule; laser-assisted fragmentation of the cataractous lens for removal during cataract surgery; and full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea. Each of which may be performed either individually or consecutively during the same procedure.

The Catalys® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Catalys® Precision Laser System is an ophthalmic surgical laser system used in healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings. The Catalys® Precision Laser System is an electromedical device which contains software. System components include a single-use Liquid Optics™ Interface and optional Mobile Patient Bed. The Catalys® Precision Laser System (also referred to as the Catalys® System or System) is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus). The Catalys® Precision Laser System laser classification per 21 CFR 1040.10 and 21 CFR 1040.11 is Class 4.

The FEMTO LDV™ Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV™ Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

The FEMTO LDV™ Z8 Femtosecond Surgical Laser is a solid state femtosecond laser used in ophthalmology. It is used for producing cuts in ocular tissue and can be used in corneal and cataract surgery. The Z8 produces femtosecond laser energy that is absorbed by the tissue, resulting in plasma formation. This plasma rapidly expands, creating a cavitation bubble separating the tissue. This process is known as photodisruption. Because of its very short pulse duration, femtosecond laser technology deploys low pulse energy that virtually eliminates damage peripheral to the incision site and can therefore be used to dissect tissue on a microscopic scale. Femtosecond laser systems may use closer spot spacing to overlap these cavitation regions, producing less tissue bridges. The FEMTO LDV™ Z8 Femtosecond Surgical Laser system consists of the following functional units: - Base Station (BS), integrating the Laser Cavity, Fixed Mirror Articulated Arm (FMAA), Power -Supply, Computer, Touchscreen Monitor, Suction Unit, OCT Box, and Safety System - Handpiece (HP) integrating the Cutting Lens and Topview Camera - Disposable accessories

The CATALYS® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Catalys® Precision Laser System ophthalmic surgical laser system used in healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings. The System is an electromedical device that contains software. System components include a single-use Liquid OpticsTM Interface and optional Mobile Patient Bed. The Catalys® Precision Laser System (also referred to as the Catalys® System or System) is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates single plane and multi-plane arccuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid OpticsTM [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus). The Catalys® Precision Laser System laser classification per 21 CFR 1040.10 and 1040.11 is Class 4.

The VICTUS Femtosecond Laser Platform is indicated for use for: · the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. • for anterior capsulotomy during cataract surgery. · the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea. · laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

The VICTUS Femtosecond Laser is a precision ophthalmic surgical laser indicated for use in patients undergoing ophthalmic surgery in the anterior segment of the eye. The VICTUS Femtosecond Laser system produces scanned patterns designed to create flaps, produce corneal incisions, arcuate incisions, capsulotomy cuts, and crystalline lens fragmentation patterns for use in cataract surgery. The patient is treated while supine on a patient bed that the physician can position electromechanically via simple controls. The physician controls the VICTUS laser system itself through a touchscreen display and other user controls. Laser emission and of PI suction vacuum are actuated by the physician using separate footswitch pedals. The mode of operation for the VICTUS Platform is using Yb:KYW Femtosecond laser to produce Laser-Induced Optical Breakdown (LIOB) of the corneal tissue. Scanned patterns of laser pulses from the VICTUS are delivered through a sterile, disposable Patient Interface (PI). The PI consists of two components: (i) a contacting lens, and (ii) a suction clip. Together, the suction clip and contacting lens connect to make a single assembly during a VICTUS procedure. The surface of the contacting lens that contacts the eye is spherically curved to match the curvature of the human eye. The suction clip assembly gently immobilizes the eye with respect to the VICTUS laser beam and optical visualization systems. The PI contacting lens and suction clip together allow for proper optical coupling of the laser and optical paths into the patient's eye and create a precise opto-mechanical reference surface for depth control of the scanning laser beam.

The CATALYS® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Catalys® Precision Laser System ophthalmic surgical laser system used in healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings. The System is an electromedical device that contains software. System components include a single-use Liquid Optics™ Interface and optional Mobile Patient Bed. The Catalys® Precision Laser System (also referred to as the Catalys® System or System) is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates single plane and multi-plane arc-cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus).

The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use: - in the creation of an anterior capsulotomy; - in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens; - in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea; - in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/ incisions in the cornea; - in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea; - in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and - in the creation of partial thickness single-plane radial cuts/incisions in the cornea.

The LLS-fs 3D with Streamline™ is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The device is also intended for use in the creation of pocket cuts/incisions in the cornea in patients undergoing ophthalmic surgery, in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea, and in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments, each of which may only be performed individually. Additionally, the device is also intended for use in the creation of partial thickness single-plane radial cuts/incisions in the cornea which may be performed individually or consecutively with arcuate incisions. Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; the size, architecture, and location of full thickness incisions within the cornea; the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea; and the size, architecture, and depth of pocket. flap, and tunnel cuts. The LLS-fs 3D with Streamline™ includes the integration with pre-op analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis-C™ (corneal) and IntelliAxis-L™ (lens) markers for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.