510(k) · Cleared
ClearedOculight GL with the Dermatology Handpiece
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 Sep 8, 1998 as substantially equivalent to K964074 (Iriderm Div., 1997) and 3 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1994. 22 later devices descend from it.
- Decided
- Sep 8, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K933880 (1994). 7 ancestors in all, the oldest K883541 (1988). 22 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 2 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 1 generation backK964074 Diolite 532Iriderm Div. · 1997
- This deviceK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- Descendant · cites it directly · 21 of its ownK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- Descendant · 2 generations on · 18 of its ownK062624 Next Generation LaserAlcon Laboratories · 2007
- Descendant · 3 generations on · 17 of its ownK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- Descendant · 4 generations on · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 5 of its ownK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K031665Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003 · cites it directly21descendants
- K062624Next Generation LaserAlcon Laboratories · 2007 · 2 generations on18descendants
- K101285Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · 3 generations on17descendants
- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · 4 generations on6descendants
- K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV · 2015 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −2 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −1 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| 0 (this device) | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| +1 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| +2 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| +3 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| +4 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| +3 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 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? (4)
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 |
|---|---|---|---|
| * | K964074 | Diolite 532Summary page 2…ht GL Laser System with the Dermatology Handpiece is substantially equivalent to other legally marketed laser systems including and the IRIDERM DioLite 532 Laser System (K964074), the Continuum Biomedical, Inc., CB Diode/532 Laser System (K954905), the Laserscope, Aura Laser System (K951034), and the HGM S… | 1997 |
| * | K954905 | CB Diode/532 Laser SystemSummary page 2…uivalent to other legally marketed laser systems including and the IRIDERM DioLite 532 Laser System (K964074), the Continuum Biomedical, Inc., CB Diode/532 Laser System (K954905), the Laserscope, Aura Laser System (K951034), and the HGM Surgica™ K1 Multi-Color Laser System (K913569). Intended Use The Ocu… | 1996 |
| * | K951034 | Aura Laser SystemSummary page 2…ems including and the IRIDERM DioLite 532 Laser System (K964074), the Continuum Biomedical, Inc., CB Diode/532 Laser System (K954905), the Laserscope, Aura Laser System (K951034), and the HGM Surgica™ K1 Multi-Color Laser System (K913569). Intended Use The OcuLight GL is currently cleared for retinal pho… | 1995 |
| * | K913569 | Compac a, Elite a, Elite a Plus, Surgica aSummary page 2…074), the Continuum Biomedical, Inc., CB Diode/532 Laser System (K954905), the Laserscope, Aura Laser System (K951034), and the HGM Surgica™ K1 Multi-Color Laser System (K913569). Intended Use The OcuLight GL is currently cleared for retinal photocoagulation and laser trabeculoplasty using ophthalmic del… | 1991 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031665 | Iris Medical Oculight GL/GLX Laser Systems | 2003 | 21 |
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 4 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K031665 (Iridex Corp, 2003) has gone furthest, with 21 descendants of its own.
- 7 other devices also cite its predicate K964074.
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 treatment of vascular and pigmented skin lesions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982031: Oculight GL with the Dermatology Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982031
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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