510(k) · Cleared
ClearedFamili of Iridex IQ Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corp · GEX Powered Laser Surgical Instrument
Cleared on Aug 7, 2008 after a 416-day review. The FDA summary names its predicate without a number. 38 later devices descend from it.
- Decided
- Aug 7, 2008
- Review
- 416 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
38 later devices descend from it, 13 citing it directly.
- This deviceK071687 Famili of Iridex IQ Laser SystemsIridex Corp · 2008
- Descendant · cites it directly · 16 of its ownK091581 Supra 577.Y LaserQuantel Medical · 2009
- Descendant · cites it directly · 15 of its ownK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
- Descendant · cites it directly · 7 of its ownK133486 Stellaris PC Vision Enhancement SystemBausch & Lomb · 2014 · Recalled
- Descendant · cites it directly · 6 of its ownK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
- Descendant · 2 generations on · 5 of its ownK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · Recalled
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K091581Supra 577.Y LaserQuantel Medical · 2009 · cites it directly16descendants
- K111108Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011 · cites it directly15descendants
- K133486Stellaris PC Vision Enhancement SystemBausch & Lomb · 2014 · cites it directly7descendants
- K121475Txcell Scanning Laser Delivery SystemIridex Corp · 2012 · cites it directly6descendants
- K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071687 | Famili of Iridex IQ Laser Systems | Iridex Corp | 2008 | — |
| +1 | K091581 | Supra 577.Y Laser | Quantel Medical | 2009 | — |
| +1 | K111108 | Pascal Streamline 577 (with Accessories) | Topcon Medical Laser Systems, Inc. | 2011 | — |
| +1 | K133486 | Stellaris PC Vision Enhancement System | Bausch & Lomb | 2014 | 3 |
| +1 | K121475 | Txcell Scanning Laser Delivery System | Iridex Corp | 2012 | — |
| +2 | K123542 | Pascal Synthesis (532NM/577NM) Opthalmic Laser | Topcon Medical Laser Systems, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (11)
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 |
|---|---|---|---|
| * | — | IRIS Medical OcuLight TX Named without a submission number | |
| * | — | IRIS Medical IQ 810 Diode Laser Named without a submission number | |
| * | — | IRIS Medical OcuLight GL/GLx Named without a submission number | |
| * | — | Asclepion Meditec AG Laser System Yellow Star Named without a submission number | |
| * | — | Lumenis Novus Varia Ophthalmic Laser Named without a submission number | |
| * | — | IRIDEX OtoProbe Named without a submission number | |
| * | — | IRIDEX D'Amico/Peyman Fluted EndoProbe Named without a submission number | |
| * | — | Straight and Illuminating LaserProbes - Adjustable Intuitive Named without a submission number | |
| * | — | IRIDEX IRIS Medical G-Probe Handpieces Named without a submission number | |
| * | — | IRIDEX IRIS Medical DioPexy Probe Handpieces Named without a submission number | |
| * | — | IRIDEX Wireless Footswitch Named without a submission number |
What descends from it? (38)
See all 3813 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091581 | Supra 577.Y Laser | 2009 | 16 |
| K111108 | Pascal Streamline 577 (with Accessories) | 2011 | 15 |
| K133486 | Stellaris PC Vision Enhancement System | 2014 | 7 |
| K121475 | Txcell Scanning Laser Delivery System | 2012 | 6 |
| K170718 | Iridex TruFocus LIO Premiere | 2017 | 3 |
| K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID) | 2015 | 3 |
| K141851 | Navilas Laser System | 2015 | 2 |
| K120825 | Supra Scan Delivery System | 2012 | 1 |
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | 2023 | 0 |
| K201502 | Vitra 810 | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091581 (Quantel Medical, 2009) has gone furthest, with 16 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]) and the 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…
Read the full statement (445 words)
The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]) and the 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
Dermatologqy
* Pigmented Skin Lesions
. Vascular Lesions
Ear, Nose, and Throat (ENT)/ Otolarynqolo-qy
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 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
810nm
Ophthalmoloqgy
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, Iidotomy, 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/K071687 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071687: Famili of Iridex IQ Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071687
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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