510(k) · Cleared
ClearedReusable Megabeam Fiber Optic Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceram Optec, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 2, 1998 as substantially equivalent to K923953 (Ceram Optec, Inc., 1992) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Jun 2, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K902990 (1990). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK902990 Coherent Holmium:Yag Surgical LaserCoherent Medical Division · 1990
- 1 generation backK960413 Coherent Slimline Single Lumen Aspiration Needle KitLumenis, Inc. · 1996
- This deviceK980838 Reusable Megabeam Fiber Optic Delivery SystemCeram Optec, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK113688 Megabeam Reusable Fiber Optic Delivery SystemBiolitec Medical Devices, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K113688Megabeam Reusable Fiber Optic Delivery SystemBiolitec Medical Devices, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902990 | Coherent Holmium:Yag Surgical Laser | Coherent Medical Division | 1990 | — |
| −1 | K960413 | Coherent Slimline Single Lumen Aspiration Needle Kit | Lumenis, Inc. | 1996 | — |
| 0 (this device) | K980838 | Reusable Megabeam Fiber Optic Delivery System | Ceram Optec, Inc. | 1998 | — |
| +1 | K113688 | Megabeam Reusable Fiber Optic Delivery System | Biolitec Medical Devices, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K923953 | MegabeamSummary page 1…Fiber Optic Delivery System Classification Name Accessory to Laser Surgical Instruments Predicate Devices CeramOptec’s disposable MegaBeam Fiber Optic Delivery Systems (K923953, K943445 and K951775), and Coherent’s SlimLine Fiber Optic Delivery System (K960413). N\\DC - 0/0 - 0594757.01… | 1992 |
| * | K943445 | Megabeam Fiber Optic Delivery SystemSummary page 1…ic Delivery System Classification Name Accessory to Laser Surgical Instruments Predicate Devices CeramOptec’s disposable MegaBeam Fiber Optic Delivery Systems (K923953, K943445 and K951775), and Coherent’s SlimLine Fiber Optic Delivery System (K960413). N\\DC - 0/0 - 0594757.01 Intended U… | 1994 |
| * | K951775 | Ceralas Diode Laser System (Model Ceralas D50)Summary page 1…System Classification Name Accessory to Laser Surgical Instruments Predicate Devices CeramOptec’s disposable MegaBeam Fiber Optic Delivery Systems (K923953, K943445 and K951775), and Coherent’s SlimLine Fiber Optic Delivery System (K960413). N\\DC - 0/0 - 0594757.01 Intended Use The reus… | 1995 |
| * | K960413 | Coherent Slimline Single Lumen Aspiration Needle KitSummary page 1…nts Predicate Devices CeramOptec’s disposable MegaBeam Fiber Optic Delivery Systems (K923953, K943445 and K951775), and Coherent’s SlimLine Fiber Optic Delivery System (K960413). N\\DC - 0/0 - 0594757.01 Intended Use The reusable MegaBeam Fiber Optic Delivery System is intended to vapori… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113688 | Megabeam Reusable Fiber Optic Delivery System | 2012 | 0 |
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 8 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K113688 (Biolitec Medical Devices, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K923953.
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 reusable MegaBeam Fiber Optic Delivery System is intended for use as an accessory to a Ho:YAG laser system to vaporize, coagulate, and incise and excise tissue, including lithrotripsy. The MegaBeam Fiber Optic Delivery System is also intended to be used in lithotripsy proccdures with Ho:YAG laser systems.
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/K980838 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980838: Reusable Megabeam Fiber Optic Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980838
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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