510(k) · Cleared
ClearedOculight GL/GLX
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 Apr 14, 2005 as substantially equivalent to K022327 (Lumenis, Inc., 2002) after a 42-day review. Its family tree reaches back 1 generation to 2002. 75 later devices descend from it.
- Decided
- Apr 14, 2005
- Review
- 42 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022327 (2002). 75 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK022327 Novus SpectraLumenis, Inc. · 2002
- This deviceK050562 Oculight GL/GLXIridex Corp · 2005
- Descendant · cites it directly · 73 of its ownK062369 Iridex Oculight TXIridex Corp · 2006
- Descendant · 2 generations on · 72 of its ownK091534 Lightlas Model 532Lightmed Corp. · 2009
- Descendant · 3 generations on · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- Descendant · 4 generations on · 46 of its ownK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- Descendant · 5 generations on · 26 of its ownK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K062369Iridex Oculight TXIridex Corp · 2006 · cites it directly73descendants
- K091534Lightlas Model 532Lightmed Corp. · 2009 · 2 generations on72descendants
- K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · 3 generations on68descendants
- K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc. · 2010 · 4 generations on46descendants
- K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011 · 5 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022327 | Novus Spectra | Lumenis, Inc. | 2002 | — |
| 0 (this device) | K050562 | Oculight GL/GLX | Iridex Corp | 2005 | — |
| +1 | K062369 | Iridex Oculight TX | Iridex Corp | 2006 | — |
| +2 | K091534 | Lightlas Model 532 | Lightmed Corp. | 2009 | — |
| +3 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| +4 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| +5 | K110080 | Radial-Emitting Shaped Fiber Optic Delivery System | Biolitec, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 8 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 9 | 0 |
| 2025 | 13 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K022327 | Novus SpectraSummary page 1…systems are substantially equivalent to other currently legally marketed ophthalmology laser devices including OeLi~SY`LAa" systems and the Lumenis Novus Spectra (K022327). Device Description The OcuLight GIJGLx is a semiconductor-based laser that delivers true continuous wave green laser… | 2002 |
| * | — | OcuLight SL/SLx Laser Systems Named without a submission number |
What descends from it? (75)
See all 752 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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 OcuLight GL/GLx is used in ophthalmic, dermatology, and ear nose and throat (ENT) applications. Specific indications are listed below: Condition: Diabetic Retinopathy * Nonproliferative Retinopathy * Macular Edema * Proliferative Retinopathy Treatment: Retinal Photocoagulation (RPC); Focal and Grid Laser Treatments Condition: Glaucoma * Primary Open Angle * Closed Angle Treatment: Laser Trabeculoplasty; Iridotomy, Iridoplasty Condition…
Read the full statement (193 words)
The IRIDEX OcuLight GL/GLx is used in ophthalmic, dermatology, and ear nose and throat (ENT) applications. Specific indications are listed below:
Condition: Diabetic Retinopathy
* Nonproliferative Retinopathy
* Macular Edema
* Proliferative Retinopathy
Treatment: Retinal Photocoagulation (RPC); Focal and Grid Laser Treatments
Condition: Glaucoma
* Primary Open Angle
* Closed Angle
Treatment: Laser Trabeculoplasty; Iridotomy, Iridoplasty
Condition: Retinal Tears and Detachments
Treatment: RPC; Focal and Grid Laser Treatments
Condition: Lattice Degeneration
Treatment: RPC; Focal and Grid Laser Treatments
Condition: Age-related Macular Degeneration (AMD)
Treatment: RPC; Focal and Grid Laser Treatments
Condition: Intra-Ocular Tumors
* Choroidal Hemangioma
* Choroidal Melanoma
* Retinoblastoma
Treatment: RPC; Focal and Grid Laser Treatments
Condition: Retinopathy of Prematurity
Treatment: RPC; Focal and Grid Laser Treatments
Condition: Sub-Retinal (choroidal) Neovascularization
Treatment: RPC; Focal and Grid Laser Treatments
Condition: Central and Branch Retinal Vein Occlusion
Treatment: RPC; Focal and Grid Laser Treatments
Condition: Dermatology
* Pigmented Skin Lesions
* Vascular lesions
Treatment: Focal Laser Treatments
Condition: Ear, Nose and Throat
* Otosclerotic hearing loss and/or diseases of the inner ear
Treatment: Stapedectomy; Stapedotomy; Myringotomies; Lysis of Adhesions; Control of Bleeding; Removal of Acoustic Neuromas; Soft tissue Adhesion in Micro/Macro Otologic Procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050562: Oculight GL/GLX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050562
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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