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The OptiMedica 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.

The Catalys Precision Laser System ("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 OptiMedica® 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.

OptiMedica's Catalys® Precision Laser System ("Catalys®System") is a Class II ophthalmic surgical laser system as defined by regulation number 21 CFR 886.4390. The Catalys® System is indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect phacofragmentation, 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. In addition to the laser classifications per 21 CFR 1040.10 and 1040.11, the Catalys® Precision Laser System complies with the requirements for Class I lasers per ANSI Z136.1-2007 as well as to ISO 15004-2:2007.

The OptiMedica® 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.

The Catalys™ Precision Laser System ("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 phacofragmentation, 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. In addition to the laser classifications per 21 CFR 1040.10 and 1040.11, the Catalys™ Precision Laser System complies with the requirements for Class I lasers per ANSI Z136.1-2007.

The OptiMedica Catalys™ Precision Laser System is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery. The anterior capsulotomy and phacofragmentation procedures may be performed either individually or consecutively during the same surgery.

The Catalys™ Precision Laser System ("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 phacofragmentation, thus facilitating efficient lens removal. 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 coregistered and provide for precise overlap between imaging and treatment beams. In addition to the laser classifications per 21 CFR 1040.10 and 1040.11, the Catalys™ Precision Laser System complies with the requirements for Class I lasers per ANSI Z136.1-2007.

The PASCAL Streamline Photocoagulator indications for use are the following: Intended for use in the treatment of ocular pathology in the posterior segment. Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy - macular edema - choroidal neovascularization - branch and central retinal vein occlusion - age-related macular degeneration - lattice degeneration - retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: - iridotomy - trabeculoplasty

The PASCAL Streamline Photocoagulator is an integrated system comprising of solid state aiming and treatment lasers, control electronics, graphical user interface, slit lamp and table. It is intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

Intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy . - macular edema . - choroidal neovascularization . - branch and central retinal vein occlusion . - age-related macular degeneration . - . lattice degeneration - retinal tears and detachments . - iridotomy, iridectomy and trabeculoplasty in angle closure and open angle . glaucoma.

The PASCAL Photocoagulator is an integrated system comprising of solid state aiming and treatment lasers, control electronics, graphical user interface, slit-lamp and table. It is intended for use in the treatment of ocular pathology in both the posterior and anterior segments. The proposed PASCAL Photocoagulator includes design modifications to the performance specifications, available scan patterns, outer housing and software to enhance product performance. No changes to the laser or the product safety have been made. The PASCAL Photocoagulator maintains the same indication for use as the predicate device, the PASCAL Photocoagulator (K043486).

The PASCAL Synthesis Delivery System is a stand alone scanning delivery system that, when connected to compatible commercially available laser photocoagulators, allows fully functional scanning photocoagulation. When connected to a compatible laser system, the PASCAL Synthesis Delivery System is indicated for use in the treatment of ocular pathology in both the posterior and anterior segments, retinal photocoagulation, pan retinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: - Proliferative and nonproliferative diabetic retinopathy - Macular edema - Choroidal neovascularization - Branch and central retinal vein occlusion - Age-related macular degeneration - Lattice degeneration - Retinal tears and detachments - Iridotomy, iridectomy and trabeculoplasty in angle closure and open angle glaucoma.

The PASCAL Synthesis Delivery System is a scanning laser delivery system that enables the use of proprietary pattern scanning technology of the PASCAL multi-spot photocoagulator (a predicate device) with other commercially available laser platforms. This offers existing commercially available laser platforms the ability to deliver a full spectrum of pattern scanning options. The PASCAL Synthesis Delivery System is intended for use by trained ophthalmologists for diagnosis and treatment of ocular pathology. The PASCAL Synthesis Delivery System consists of the following system components: - 1) Scanning laser delivery system integrated into an Optimedica slit lamp with LCD/Touchscreen GUI that can be positioned by the user for optimal access and viewing. - 2) Scanner control module with scanner controls, power supply, electronics, optical fiber & electrical connections integrated into a slit lamp table. The PASCAL Synthesis Delivery System is compatible with the following commercially available laser systems: - Alcon Ophthalas 532 Eyelite Laser Photocoagulator - Zeiss Visulas 532s

The OptiMedica LIO is indicated for the delivery of laser energy in eyes with retinal pathology. The OptiMedica LIO is indicated for use in the following ophthalmic treatments and conditions: - . Diabetic retinopathy (panretinal photocoagulation) - . Macular degeneration - Peripheral neovascularization . - ◆ Retinal breaks - Retinal detachments - . Retinal tears - Lattice degeneration - Pneumatic retinopexy reattachment procedures . - . Segmental peripheral photocoagulation - . Segmental photocoagulation - . Cloudy vitreous cavities - Pediatric retinal repairs (under general anesthesia) . - . Delivery of laser energy through small pupils or to eyes with focal lens opacities

The OptiMedica Laser Indirect Ophthalmoscope (LIO) is intended for use in the diagnosis and treatment of ocular pathology. The LIO illuminates and magnifies the fundus image. When connected to the Pascal Retinal Photocoagulator, the laser aiming and treatment beams are precisely focused and delivered to the patient's eye through the LIO.