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When the TxCell Scanning Laser Delivery System is connected to the IQ 532 (532 nm), the IQ 577 (577 nm) or the IQ 810 (810 nm) Laser Console, from the IRIDEX Family of IQ Laser Systems and used to deliver laser energy in CW-Pulse, MicroPulse or LongPulse mode, it is intended to be used by a trained ophthalmologist for the treatment of ocular pathology of both the anterior and posterior segments of the eye. 532 nm: Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including: Retinal photocoagulation (RPC) for the treatment of: Diabetic retinopathy, including: Nonproliferative retinopathy, Macular edema, Proliferative retinopathy; Retinal tears and detachments; Lattice degeneration; Age-related macular degeneration (AMD) with choroidal neovascularization (CNV); Sub-retinal (choroidal) neovascularization; Central and branch retinal vein occlusion; Laser trabeculoplasty for the treatment of: Primary open angle glaucoma; Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma. 577 nm: Indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation of vascular and structure abnormalities of the retina and choroid including: Proliferative and nonproliferative diabetic retinopathy; Choroidal neovascularization; Branch retinal vein occlusion; Age-related macular degeneration (AMD) with choroidal neovascularization (CNV); Retinal tears and detachments; Laser trabeculoplasty for the treatment of: Primary open angle glaucoma; Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma. 810 nm: Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy including: Retinal photocoagulation for the treatment of: Diabetic retinopathy, including: Nonproliferative retinopathy, Macular edema, Proliferative retinopathy; Retinal tears, detachments and hole; Lattice degeneration; Age-related macular degeneration (AMD) with choroidal neovascularization (CNV); Sub-retinal (choroidal) neovascularization; Central and branch retinal vein occlusion; Laser trabeculoplasty for the treatment of: Primary open angle glaucoma; Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma.

The TxCell™ Scanning Laser Delivery System is a slit lamp adapter laser delivery system which is installed by the customer on existing slit lamps in their office or clinic and is used by ophthalmologists to deliver laser energy to various ocular targets. The TxCell™ delivery system delivers laser applications in both single spot mode and multi-spot mode. The TxCell™ Scanning Laser Delivery System adds the use of multi-spot pattern scanning technology when coupling with commercially available IRIDEX laser systems. This offers existing IRIDEX laser systems the ability to deliver, in addition to standard single spot applications, a full spectrum of multi-spot pattern scanning options through a variety of customer owned slit lamps. The TxCell™ Scanning Laser Delivery System consists of the following system components: TxCell™ Scanning Slit Lamp Adapter (SSLA) that may be coupled to Zeiss-style or Haag Streit-style slit lamps or the IRIDEX Laser Workstations. TxCell™ Control Box with power supply, scanner controller, drive electronics and electrical connections. The Control Box is paired with an SSLA. Cables to connect the SSLA to the Control Box and the Control Box to the laser console. The TxCell Scanning Laser Delivery System requires connection to a TxCell compatible Laser Console from the IRIDEX Family of IQ Laser Systems (IQ 532, IQ 577, IQ 810). The touchscreen on the TxCell compatible IQ Family Laser Console accesses a Pattern Selection Screen and the knobs on the Laser Console set the pattern parameters. All other user interface screens and menus are unchanged and operate the same as on the standard IQ Family Laser Console.

The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]) and the hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™,or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of , dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows: 532 nm Dermatology · Pigmented Skin Lesions · Vascular Lesions Ear. Nose, and Throat (ENT)/ Otolaryngology Otosclerotic Hearing loss and/or diseases of the inner ear: · Stapedectomy · Stapedotomy · Myringotomies Lysis of Adhesions · Control of Bleeding · Removal of Acoustic Neuromas " Soft tissue Adhesion in Micro/Macro Otologic Procedures Ophthalmology Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including: · Retinal photocoagulation (RPC) for the treatment of > Diabetic retinopathy, including: Nonproliferative retinopathy Macular edema Proliferative retinopathy > Retinal tears and detachments > Lattice degeneration > Age-related macular degeneration (AMD) > Retinopathy of prematurity > Sub-retinal (choroidal) neovascularization > Central and branch retinal vein occlusion · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including > Primary open angle/Closed angle 577nm Dermatology: · Treatment of Vascular and pigmented lesions Ophthalmology: Indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation and intravitreal ● endophotocoagulation of vascular and structural abnormalities of the retina and choroids including : > proliferative and nonproliferative diabetic retinopathy; > choroidal neovascularization; > branch retinal vein occlusion; > age-related macular degeneration > retinal tears and detachments > retinopathy of prematurity Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle . Glaucoma 630 - 670nm Ophthalmology: Indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation and intravitreal . endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: > proliferative and nonproliferative diabetic retinopathy; > choroidal neovascularization; > branch retinal vein occlusion; > age-related macular degeneration > retinal tears and detachments > retinopathy of prematurity Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open . angle glaucoma 810nm Opthalmology: Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following: · Retinal photocoagulation for the treatment of: > Diabetic retinopathy including; Nonproliferative retinopathy Macular edema Proliferative retinopathy > Retinal Tears, Detachments and Holes > Lattice degeneration > Age-related macular degeneration (AMD) with choroidal neovascularizations (CNV) > Retinopathy of prematurity > Sub-retinal (choroidal) neovascularization > Central and Branch Retinal Vein Occlusion Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) . for the treatment of glaucoma, including; > Primary open angle > Closed angle > Refractory Glaucoma (recalcitrant/uncontrolled)

The Family of IRIDEX IQ Laser Systems is comprised of the following main components: Main console containing the major electrical components, including: . A Control Panel including control knobs (power, interval, duration or software assigned function), treat/standby button, and display; Two delivery device fiber-optic connector ports (only one active at a time); A A LIO illumination connection: Smart key port for detecting/operating safety filters and/or accessory A identification: A Emergency stop switch: A Kev switch: Connector ports for the footswitch, remote control, and power cord; A A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust); . A Wired Remote Control that duplicates the control panel; . Delivery Accessories including OtoProbe handpieces, EndoProbe handpieces, . G-Probe and DioPexy Probe Handpieces, Dermatology Handpieces, Microscope Adapters, and Laser Indirect Ophthalmoscopes. . Optional Cart/Stand

The IRIDEX Wireless Footswitch is intended for use with compatible IRIDEX Laser Systems operated in hospital or outpatient facilities. The IRIDEX Wireless Footswitch is indicated for use as an accessory to provide input control of laser emission to compatible IRIDEX Laser Systems. This accessory includes a wireless footswitch and a receiver. It is cleared for use for the particular indications of the laser system to which it is attached.

The Wireless Footswitch is an alternate option to the existing cabled footswitch for users of IRIDEX laser consoles. It consists of two discreet parts - a footswitch/transmitter and receiver. The wireless footswitch receiver connects to the laser through the same connector as the current wired footswitch, and operates with the console by directly emulating the functionality of the current wired footswitch.

The OcuLight TX is intended for use in otolaryngological, dermatological and ophthalmic surgical procedures. In otolaryngology it is indicated for stapedectomy, stapedotomy, myringotomy, lysis of adhesions, control of bleeding, removal of acoustic neuromas, and soft tissue adhesion in micro/macro otologic procedures. In dermatology it is indicated for the treatment of vascular and pigmented skin lesions. In ophthalmology it is indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, and iridoplasty.

The OcuLight TX is a solid state laser that delivers true continuous wave green laser (532 nm) light for otolaryngologic, dermatology, and ophthalmic applications. The integrated system is comprised of the OcuLight TX laser console, various compatible optical fiber delivery devices, and a Footswitch. The laser console contains the laser head, imaging optics, power supplies, control electronics, and firmware. The electronic system is comprised of various sense and control electronics, user controls and displays, and an embedded microprocessor that monitors all system functions. The microprocessor interprets operator commands, formats displays and supervises laser emission. A visible red (630-650 nm) semiconductor diode laser is used for aiming.

The IRIDEX OtoProbe is intended for use in surgical procedures for use in incision, excision, coagulation, and vaporization of soft and fibrous tissue including osseous tissue in the medical specialty of ENT surgery. The IRIDEX OtoProbe is cleared for use for the particular indications of the compatible laser system to which it is attached.

The IRIDEX OtoProbe is comprised of the following main components: - A glass fiber optic protected by a medical grade stainless steel needle and handle at the distal (patient) end and by a plastic jacket at the proximal (laser connection) end: and - . A universal SMA laser connector. The IRIDEX OtoProbe is provided as a sterile, single use laser energy delivery system device (accessory). The universal SMA connector at the proximal end of the optical fiber delivery device is designed to be attached to the optical fiber Laser Port of the IRIDEX OcuLight laser system or other 532 nm laser system with universal SMA compatibility that has been qualified by IRIDEX for use with the IRIDEX OtoProbe.

The IRIDEX OcuLight GL/GLx is used in ophthalmic, dermatology, and ear nose and throat (ENT) applications. Specific indications are listed below: Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy): Retinal Photocoagulation (RPC); Focal and Grid Laser Treatments Glaucoma (Primary Open Angle, Closed Angle): Laser Trabeculoplasty; Iridotomy, Iridoplasty Retinal Tears and Detachments: RPC; Focal and Grid Laser Treatments Lattice Degeneration: RPC; Focal and Grid Laser Treatments Age-related Macular Degeneration (AMD): RPC; Focal and Grid Laser Treatments Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma): RPC; Focal and Grid Laser Treatments Retinopathy of Prematurity: RPC; Focal and Grid Laser Treatments Sub-Retinal (choroidal) Neovascularization: RPC; Focal and Grid Laser Treatments Central and Branch Retinal Vein Occlusion: RPC; Focal and Grid Laser Treatments Dermatology (Pigmented Skin Lesions, Vascular lesions): Focal Laser Treatments Ear, Nose and Throat (Otosclerotic hearing loss and/or diseases of the inner ear): Stapedectomy, Stapedotomy, Myringotomies, Lysis of Adhesions, Control of Bleeding, Removal of Acoustic Neuromas, Soft tissue Adhesion in Micro/Macro Otologic Procedures

The OcuLight GL/GLx is a semiconductor-based laser that delivers true continuous wave green laser (532 nm) light for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. Visible red (630-650 nm) semiconductor diode laser is used for aiming.

The IQ 810 is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cvclophotocoagulation, transscleral retinal photocoagulation, iridotomy, and other laser diode treatments. The following are examples of applications for the IQ 810 laser systems. | Condition | Treatment | |----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Diabetic Retinopathy Nonproliferative Retinopathy Macular Edema Proliferative Retinopathy | Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments | | Glaucoma Primary Open Angle Closed Angle Refractory Glaucoma<br>(recalcitrant/uncontrolled) | Laser Trabeculoplasty; Iridotomy;<br>Transscleral Cyclophotocoagulation<br>(TSCPC) | | Retinal Tears, Detachments, and Holes | Transscleral Retinal Photocoagulation<br>(TSRPC); Focal and Grid Laser<br>Treatments | | Lattice Degeneration | PRP; Focal and Grid Laser Treatments | | Age-related Macular Degeneration (AMD)<br>with Choroidal Neovascularization (CNV) | Focal and Grid Laser Treatments | | Intra-Ocular Tumors Choroidal Hemangioma Choroidal Melanoma Retinoblastoma | Focal and Grid Laser Treatments | | Retinopathy of Prematurity | PRP; TSRPC; Focal and Grid Laser<br>Treatments | | Sub-Retinal (choroidal) Neovascularization | Focal and Grid Laser Treatments | | Central and Branch Retinal Vein Occlusion | PRP; Focal and Grid Laser Treatments |

The IQ 810 is a semiconductor diode laser system that delivers infrared 810 nm laser light intended to be used for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and iridotomy. Visible red (630-650 nm) semiconductor diode laser is used for aiming.

The IRIDEX OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. The following are examples of applications for the OcuLight GL/GLx laser systems. | Condition | Treatment | |--------------------------------------------|--------------------------------------------------------------------| | Diabetic Retinopathy | Retinal Photocoagulation (RPC); Focal<br>and Grid Laser Treatments | | • Nonproliferative Retinopathy | | | • Macular Edema | | | • Proliferative Retinopathy | | | Glaucoma | Laser Trabeculoplasty; Iridotomy,<br>Iridoplasty | | • Primary Open Angle | | | • Closed Angle | | | • Refractory Glaucoma | | | Retinal Tears and Detachments | RPC; Focal and Grid Laser Treatments | | Lattice Degeneration | RPC; Focal and Grid Laser Treatments | | Age-related Macular Degeneration (AMD) | RPC; Focal and Grid Laser Treatments | | Intra-Ocular Tumors | RPC; Focal and Grid Laser Treatments | | • Choroidal Hemangioma | | | • Choroidal Melanoma | | | • Retinoblastoma | | | Retinopathy of Prematurity | RPC; Focal and Grid Laser Treatments | | Sub-Retinal (choroidal) Neovascularization | RPC; Focal and Grid Laser Treatments | | Central and Branch Retinal Vein Occlusion | RPC; Focal and Grid Laser Treatments | | Dermatology | Focal Laser Treatments | | • Pigmented Skin Lesions | | | • Vascular lesions | | | Ear, Nose and Throat | Stapedotomy | | • Otosclerotic hearing loss | |

The OcuLight GL/GLx is a semiconductor-based laser that delivers true continuous wave green laser (532 nm) light for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. Visible red (630-650 nm) semiconductor diode laser is used for aiming.

The family of IRIS Medical EndoProbe handpieces is intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the aspiration function is indicated for use when unwanted fluid is present in the eye causing refraction or scattering of the laser beam from the intended treatment site, and the illumination function is indicated for use to illuminate the interior of the eye. The handpieces are offered in straight or angled styles, and with a universal SMA connector that allows the family of EndoProbe handpieces to be used with compatible laser systems, such as IRIS Medical and Lumenis. The handpieces are cleared for use for the particular indications of the laser system to which they are attached.

The family of IRIS Medical EndoProbe handpieces is comprised of the following main components: a universal SMA style input connector, a glass fiber optic protected by a PVC (vinyl) jacket, a handle, and a medical grade stainless steel needle. The Illuminating EndoProbe has an additional illumination fiber optic with jacket.

The IRIDEX® Apex 800 Laser System is indicated for hair removal and permanent hair reduction on all skin types (Fitzpatrick skin types I-VI), including tanned skin; for the treatment of pseudofolliculitis barbae; for the treatment of vascular lesions including angiomas, hemangiomas, telangiectasia; for the treatment of leg veins; and for the treatment of benign pigmented lesions.

The Apex 800 is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light.