510(k) · Cleared
ClearedIridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corporation · HQF Laser, Ophthalmic
Cleared on Feb 23, 2023 as substantially equivalent to K071687 (Iridex Corp, 2008) after a 27-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Feb 23, 2023
- Review
- 27 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071687 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK071687 Famili of Iridex IQ Laser SystemsIridex Corp · 2008
- This deviceK230228 Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm…Iridex Corporation · 2023
View 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) | K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | Iridex Corporation | 2023 | — |
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 HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 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 5…Laser Console Company: Iridex Corporation Device: Collectively: Family of IRIDEX IQ® Laser Systems (IQ532, IQ577) (K071687) Individual Models: Iridex IQ 532® Laser System, Iridex I… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 12 other devices also cite its predicate K071687.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, 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 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Iridex® Laser Console (532 model and 577 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse) or MicroPulse® mode, for ophthalmic applications (532 and 577 models) and for Ear, Nose, and Throat (Otolaryngology) applications (532 model only). Iridex® 532 Laser The Iridex® 532 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation…
Read the full statement (309 words)
The Iridex® Laser Console (532 model and 577 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse) or MicroPulse® mode, for ophthalmic applications (532 and 577 models) and for Ear, Nose, and Throat (Otolaryngology) applications (532 model only).
Iridex® 532 Laser
The Iridex® 532 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, ear, nose and throat (ENT)/otolaryngology, and ophthalmology as follows:
Ophthalmology
Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:
• Retinal photocoagulation (RPC) for the treatment of
o Diabetic retinopathy, including:
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
o Retinal tears and detachments
o Lattice degeneration
o Age-related macular degeneration (AMD)
o Retinopathy of prematurity
o Sub-retinal (choroidal) neovascularization
o Central and branch retinal vein occlusion
• Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
o Primary open angle/Closed angle
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
Iridex® 577 Laser
The Iridex® 577 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialty of ophthalmology as follows:
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:
o Proliferative and nonproliferative diabetic retinopathy
o Choroidal neovascularization
o Branch retinal vein occlusion
o Age-related macular degeneration (AMD)
o Retinal tears and detachments
o Retinopathy of prematurity
• Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230228: Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230228
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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