510(k) · Cleared
ClearedIridex Oculight TX
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 Nov 8, 2006 as substantially equivalent to K050562 (Iridex Corp, 2005) and 3 other predicates after an 86-day review. Its family tree reaches back 8 generations to 1992. 73 later devices descend from it.
- Decided
- Nov 8, 2006
- Review
- 86 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K910422 (1992). 98 ancestors in all, the oldest K820106 (1982). 73 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 4 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 3 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 2 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 1 generation backK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
- This deviceK062369 Iridex Oculight TXIridex Corp · 2006
- Descendant · cites it directly · 72 of its ownK091534 Lightlas Model 532Lightmed Corp. · 2009
- Descendant · 2 generations on · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- Descendant · 3 generations on · 46 of its ownK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- Descendant · 4 generations on · 26 of its ownK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
- Descendant · 5 generations on · 24 of its ownK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K091534Lightlas Model 532Lightmed Corp. · 2009 · cites it directly72descendants
- K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · 2 generations on68descendants
- K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc. · 2010 · 3 generations on46descendants
- K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011 · 4 generations on26descendants
- K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −7 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −5 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −4 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −3 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −2 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| −1 | K032220 | Adept 1064/532 Laser | Adept Medical Concepts | 2003 | — |
| 0 (this device) | K062369 | Iridex Oculight TX | Iridex Corp | 2006 | — |
| +1 | K091534 | Lightlas Model 532 | Lightmed Corp. | 2009 | — |
| +2 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| +3 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| +4 | K110080 | Radial-Emitting Shaped Fiber Optic Delivery System | Biolitec, Inc. | 2011 | — |
| +5 | K120810 | Fiberoptic Laser Delivery System | Fiberoptic Fabrications, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 12 | 0 |
| 2002 | 13 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K050562 | Oculight GL/GLXSummary page 1…X Primary Classification Names: Laser Powered Surgical Instrument; Laser, Ophthalmic III. Predicate Devices * IRIS Medical OcuLight GL/GLx (K050562) * Leminis Inc. Novus Spectra (K022327) * Adept Medical Concepts, Inc Quanta (K032220) * B… | 2005 |
| * | K022327 | Novus SpectraSummary page 1…ered Surgical Instrument; Laser, Ophthalmic III. Predicate Devices * IRIS Medical OcuLight GL/GLx (K050562) * Leminis Inc. Novus Spectra (K022327) * Adept Medical Concepts, Inc Quanta (K032220) * Biolitec AG (K002296) IV. Product Description… | 2002 |
| * | K032220 | Adept 1064/532 LaserSummary page 1…ate Devices * IRIS Medical OcuLight GL/GLx (K050562) * Leminis Inc. Novus Spectra (K022327) * Adept Medical Concepts, Inc Quanta (K032220) * Biolitec AG (K002296) IV. Product Description The OcuLight TX is a solid state laser that delivers… | 2003 |
| * | K002296 | Ceralas G15 532NM Frequency Doubled ND:Yag Laser, Model G1-G15Summary page 1…cal OcuLight GL/GLx (K050562) * Leminis Inc. Novus Spectra (K022327) * Adept Medical Concepts, Inc Quanta (K032220) * Biolitec AG (K002296) IV. Product Description The OcuLight TX is a solid state laser that delivers true continuous wave green laser (532… | 2000 |
What descends from it? (73)
See all 731 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091534 | Lightlas Model 532 | 2009 | 72 |
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 14 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 98 ancestors have a recall of any class.
- Of its descendants, K091534 (Lightmed Corp., 2009) has gone furthest, with 72 descendants of its own.
- 1 other device also cites its predicate K050562.
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 OcuLight TX is intended to be used in ENT surgery for tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis. Indications for use include, but are not limited to: Stapedectomy, Stapedotomy Myringotomy Lysis of adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in Micro/Macro Otologic Procedures The OcuLight TX is intended to photocoagulate issue in dermatological procedures. Indications for…
Read the full statement (96 words)
The OcuLight TX is intended to be used in ENT surgery for tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis. Indications for use include, but are not limited to:
Stapedectomy,
Stapedotomy
Myringotomy
Lysis of adhesions
Control of Bleeding
Removal of Acoustic Neuromas
Soft Tissue Adhesion in Micro/Macro Otologic Procedures
The OcuLight TX is intended to photocoagulate issue in dermatological procedures. Indications for use include:
Focal laser treatment of vascular and pigmented skin lesions.
The OcuLight TX is intended to photocoagulate ocular tissue in ophthalmic procedures. Indications for use include:
Retinal Photocoagulation
Laser Trabeculoplasty
Iridotomy
Iridoplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062369: Iridex Oculight TX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062369
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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