Iridex TruFocus LIO Premiere

The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), 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 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

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 non-proliferative 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 glaucoma and open angle glaucoma

810nm
Ophthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following example

The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), 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 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 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: - Prolifera

The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope is a light combination and reflection viewing system used with the Iridex IQ/GL/SL/TX laser system families. The LIO combines a laser treatment beam from an Iridex laser source with the illumination beam of a Heine binocular indirect ophthalmoscope into a mixed optical beam used by a physician with a handheld ophthalmic examination (condensing) lens to enter a patient's pupil and to collect and view reflections by a patient's retina returned through the same pupil. It provides a portable alternative to patients who cannot be examined or treated with a fixed slit lamp adapter. The LIO is supplied non-sterile and is intended for reuse and worn on the physician's head to view and treat the patient's retina. The device can be used to evaluate and treat patients of all ages, including infants, in an office, operating room and ambulatory surgical center setting. There are five models of the TruFocus LIO Premiere available that differ in the laser wavelength to be delivered, spot size, and the type of LIO-to-laser console connector, as listed in the table below. Each LIO includes: • Accessory Kit (PN 87526) comprised of a carry case (PN 87284), headband-mounted rechargeable battery (PN 87287), and a plug-in transformer (PN 87286). These accessories are also available for individual purchase. • LIO instructions are provided in the form of an Operator Manual. • Heine Omega 500 BIO instructions are included. • Zero-diopter and Two-diopter lenses are included. Other available options include: • Extension cord for plug-in transformer • Wall-mounted charging cradle Key Functional Components The TruFocus LIO Premiere contains the following hardware components: • Adjustable headband • Headband-mounted rechargeable battery • Headband-mounted optics unit • Fiber-optic cable with connector (resistive or RFID) • Zero-diopter and Two-diopter lenses • Plug-in transformer and extension cord • Wall-mounted charging cradle • Replaceable LED illumination bulb • Standard carry case