510(k) · Cleared
ClearedIris Medical Oculight GL/GLX Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corp · HQF Laser, Ophthalmic
Cleared on Aug 27, 2003 as substantially equivalent to K960971 (Iriderm Div., 1996) and 4 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1994. 21 later devices descend from it.
- Decided
- Aug 27, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K933880 (1994). 19 ancestors in all, the oldest K883541 (1988). 21 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 3 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 2 generations backK964074 Diolite 532Iriderm Div. · 1997
- 1 generation backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- This deviceK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- Descendant · cites it directly · 18 of its ownK062624 Next Generation LaserAlcon Laboratories · 2007
- Descendant · 2 generations on · 17 of its ownK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- Descendant · 3 generations on · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- Descendant · 4 generations on · 3 of its ownK161794 CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K062624Next Generation LaserAlcon Laboratories · 2007 · cites it directly18descendants
- K101285Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · 2 generations on17descendants
- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · 3 generations on6descendants
- K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV · 2015 · 2 generations on5descendants
- K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −3 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −2 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −1 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| 0 (this device) | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| +1 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| +2 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| +3 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| +2 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
| +4 | K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 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? (5)
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 |
|---|---|---|---|
| * | K960971 | Oculight GLSummary page 1…stems are substantially equivalent to other currently legally markctcd ophthalmology laser devices including lRlDEX Corporation's IRIS Medical OcuLight GL Laser (IC960971 and K98203 I), the IRTS Medical OcuLight SL/SLx Laser (K020374), the Lumenis Novus Spectra (K022327), and the Alcon UphthaI… | 1996 |
| * | K982031 | Oculight GL with the Dermatology Handpiece | 1998 |
| * | K020374 | Oculight SL/SLXSummary page 1…markctcd ophthalmology laser devices including lRlDEX Corporation's IRIS Medical OcuLight GL Laser (IC960971 and K98203 I), the IRTS Medical OcuLight SL/SLx Laser (K020374), the Lumenis Novus Spectra (K022327), and the Alcon UphthaIa~@532 Laser (K962592). Device Description The OcuLight GWGLx… | 2002 |
| * | K022327 | Novus SpectraSummary page 1…including lRlDEX Corporation's IRIS Medical OcuLight GL Laser (IC960971 and K98203 I), the IRTS Medical OcuLight SL/SLx Laser (K020374), the Lumenis Novus Spectra (K022327), and the Alcon UphthaIa~@532 Laser (K962592). Device Description The OcuLight GWGLx is a semiconductor-based laser that… | 2002 |
| * | K962592 | Ophthalas 532 Solid State Photocoagulator, or Equivalent Laser SystemsSummary page 1…cuLight GL Laser (IC960971 and K98203 I), the IRTS Medical OcuLight SL/SLx Laser (K020374), the Lumenis Novus Spectra (K022327), and the Alcon UphthaIa~@532 Laser (K962592). Device Description The OcuLight GWGLx is a semiconductor-based laser that delivers true continuous wave green laser (53… | 1996 |
What descends from it? (21)
See all 213 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K062624 (Alcon Laboratories, 2007) has gone furthest, with 18 descendants of its own.
- 4 other devices also cite its predicate K960971.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 RIDEX OcuLight CUGLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. The following are examples of appkatioas for the OcuLight GWGLx laser systems. Condition Treatment Diabetic Retinopathy Retinal Photocoagulation (RPC); Focal Nonproliferative Retinopathy and Chid Laser Treatments MacularEdema Proliferative Retinopathy Glaucoma Laser Trabeculoplasty…
Read the full statement (154 words)
The RIDEX OcuLight CUGLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. The following are examples of appkatioas for the OcuLight GWGLx laser systems.
Condition Treatment
Diabetic Retinopathy Retinal Photocoagulation (RPC); Focal
Nonproliferative Retinopathy and Chid Laser Treatments
MacularEdema
Proliferative Retinopathy
Glaucoma Laser Trabeculoplasty; Iridotomy,
Primary Open Angle Jiidoplasty
Closed Angle
Retinal Tears and Detachments RPC; Focal and Grid Laser Treatments
Condition Treatment
Lattice Degeneration FWC; Focal and Grki Laser Treatments
Age-related Macular Degeneration (AMD) RPC; Focal and Grid Laser Treatments
Intra-Ocular Tumors RPC;Focal and Grid Laser Treatments
Choroidal Hemangioma
Choroidal Melanoma
Retinoblastoma
Retinopathy of Prematurity RPC; Focal and Grid Laser Treatments
Sub-Retinal (choroidal) Neovasculaiization RPC; Focal and Grid Laser Treatments
Central and Branch Retinal Vein Occlusion RPC; Focal and Grid Laser Treatments
Dermatology Focal Laser Treatments
Pigmented Skin Lesions
Vascular lesions
Ear, Nose and Throat Stapedotomy
Otosclerotic Wearing t o s s
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031665 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031665: Iris Medical Oculight GL/GLX Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031665
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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