510(k) · Cleared
Recalled · Class II · 2017Optilite Holmium Laser Fibers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jan 23, 2008 as substantially equivalent to K994010 (Innovaquartz, 1999) and 1 other predicate after a 42-day review. Its family tree reaches back 1 generation to 1999. 4 later devices descend from it. It has been recalled once.
- Decided
- Jan 23, 2008
- Review
- 42 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992866 (1999). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK992866 Optilite IX Laser Surgery AccessoriesConvergent Laser Technologies · 1999 · Recalled
- This deviceK073496 Optilite Holmium Laser FibersCook Urological, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK124030 Cook Holmium Laser FiberCook Incorporated · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK163197 Cook Holmium Laser FiberCook Incorporated · 2017
- Descendant · 2 generations on · 0 of its ownK133788 Cook Holmium Laser FiberCook Incorporated · 2015
- Descendant · cites it directly · 0 of its ownK090281 Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K124030Cook Holmium Laser FiberCook Incorporated · 2013 · cites it directly2descendants
- K163197Cook Holmium Laser FiberCook Incorporated · 2017 · 2 generations on0descendants
- K133788Cook Holmium Laser FiberCook Incorporated · 2015 · 2 generations on0descendants
- K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992866 | Optilite IX Laser Surgery Accessories | Convergent Laser Technologies | 1999 | 2 |
| 0 (this device) | K073496 | Optilite Holmium Laser Fibers | Cook Urological, Inc. | 2008 | — |
| +1 | K124030 | Cook Holmium Laser Fiber | Cook Incorporated | 2013 | 1 |
| +2 | K163197 | Cook Holmium Laser Fiber | Cook Incorporated | 2017 | — |
| +2 | K133788 | Cook Holmium Laser Fiber | Cook Incorporated | 2015 | — |
| +1 | K090281 | Accutech Family of Powerflex Laser Delivery Devices | Accutech Medical Technologies, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K994010 | Innovaquartz General Shape Laser FiberSummary page 1…d technology to existing predicate devices incommercial distribution. Specifically, the OptiLitemHolmium Laser Fibers are similar to the AccuFlexTM Holmium Laser Fibers (K994010) manufactured by InnovaQuartz, Incorporated, distributed by Boston Scientific Corporation. The OptiLiteTMHolmium Laser Fibers are… | 1999 |
| * | K992866 | Optilite IX Laser Surgery AccessoriesSummary page 1…nnovaQuartz, Incorporated, distributed by Boston Scientific Corporation. The OptiLiteTMHolmium Laser Fibers are identical to the OptiLITE TM IXLaser Surgery Accessories (K992866) manufactured by Convergent Laser Technologies and distributed by Cook Urological, Incorporated. Device Description: The OptiLi… | 1999 |
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 3, 2017 | Class II | Z-2585-2017 | Device Design | Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection… |
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. 2008, this device’s year, is highlighted.
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?
Indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG wavelengths for the indications for which the lasers have been cleared.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073496: Optilite Holmium Laser Fibers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073496
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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