Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
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).
Summary parsed at:2026-06-01 05:59:52 UTC