# K181662: Iridex TruFocus LIO Premiere

- Pathway: 510(k) (Special)
- Applicant: Iridex Corporation
- Decided: Sep 5, 2018 after 72 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K071687 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170718: Iridex TruFocus LIO Premiere, Iridex Corporation (2017) Summary page 6.

## Indications for use
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 examples: • 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 neovascularization (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)

Source page: https://510kreport.com/device/K181662
Methodology: https://510kreport.com/methodology