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]) is 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:
• 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 examples:
• Retinal photocoagulation for the treatment of:
  - Diabetic retinopathy, including:
    - Nonproliferative retinopathy
    - Macular edema
 

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

Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], and IQ 810 [810nm]), hand pieces, delivery devices & accessories is a delivery accessory used with the Iridex family of IQ laser systems (IQ532, IQ577, and IQ810). Iridex TruFocus LIO Premiere and 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 is a head-mounted diagnostic indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient's retina. It allows binocular visualization of the peripheral retina not easily viewed at the slit lamp and can be used to evaluate and treat patients, including infants, while they are in a supine position. The LIO is a laser delivery device used to perform transpupillary laser photocoagulation during non-invasive ocular surgical procedures. The LIO is supplied non-sterile and is intended for reuse. Variants of the device may relate to the style of headband, laser wavelength to be delivered, and the device to laser connector (i.e. RFID).