# K170718: Iridex TruFocus LIO Premiere

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corporation
- Decided: May 3, 2017 after 55 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K071687 (2008). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071687: Famili of Iridex IQ Laser Systems, Iridex Corp (2008) Summary page 6.

## Most influential descendants
- K201623: LION Photocoagulator (2020), 1 descendant of its own
- K251507: Integre Lio (2026), 0 descendants of its own
- K181662: Iridex TruFocus LIO Premiere (2018), 0 descendants of its own

## Recalls of this device
- Feb 27, 2018 · Class II · Z-1075-2018: It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.

## 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, MicroPulseTM or LongPulse TM 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/K170718
Methodology: https://510kreport.com/methodology