510(k) · Cleared
Recalled · Class II · 2018Iridex TruFocus LIO Premiere
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corporation · GEX Powered Laser Surgical Instrument
Cleared on May 3, 2017 as substantially equivalent to K071687 (Iridex Corp, 2008) after a 55-day review. Its family tree reaches back 1 generation to 2008. 3 later devices descend from it. It has been recalled once.
- Decided
- May 3, 2017
- Review
- 55 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071687 (2008). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK071687 Famili of Iridex IQ Laser SystemsIridex Corp · 2008
- This deviceK170718 Iridex TruFocus LIO PremiereIridex Corporation · 2017
- Descendant · cites it directly · 1 of its ownK201623 LION PhotocoagulatorNorlase Aps · 2020
- Descendant · 2 generations on · 0 of its ownK251507 Integre LioQuantel Medical · 2026
- Descendant · cites it directly · 0 of its ownK181662 Iridex TruFocus LIO PremiereIridex Corporation · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071687 | Famili of Iridex IQ Laser Systems | Iridex Corp | 2008 | — |
| 0 (this device) | K170718 | Iridex TruFocus LIO Premiere | Iridex Corporation | 2017 | — |
| +1 | K201623 | LION Photocoagulator | Norlase Aps | 2020 | — |
| +2 | K251507 | Integre Lio | Quantel Medical | 2026 | — |
| +1 | K181662 | Iridex TruFocus LIO Premiere | Iridex Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071687 | Famili of Iridex IQ Laser SystemsSummary page 6…lmoscope Common Name: Laser Indirect Ophthalmoscope Classification Name: Laser Powered Surgical Instruments (and Accessories) 510(k) Number: K071687 Manufacturer: IRIS Medical Instruments, Inc. /Iridex Corporation Device Description: Iridex TruFocus LIO Premiere w… | 2008 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2018 | Class II | Z-1075-2018 | Device Design | It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (459 words)
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170718: Iridex TruFocus LIO Premiere.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170718
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026