510(k) · Cleared
ClearedMegabeam Fiber Optic Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hogan & Hartson · GEX Powered Laser Surgical Instrument
Cleared on Feb 10, 1995 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 10, 1995
- Review
- 43 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK946336 Megabeam Fiber Optic Delivery SystemHogan & Hartson · 1995
- Descendant · cites it directly · 3 of its ownK980389 Megabeam Reusable Fiber Optic Handpiece and NeedlesCeram Optec, Inc. · 1998
- Descendant · 2 generations on · 1 of its ownK061025 Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK113709 Megabeam Fiber Optic Delivery System with Additional Tips & HandpieceBiolitec Medical Devices, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK090281 Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK060905 Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1Iridex Corp · 2006
Most influential descendants
Showing 5 of 5 · See all- K980389Megabeam Reusable Fiber Optic Handpiece and NeedlesCeram Optec, Inc. · 1998 · cites it directly3descendants
- K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006 · 2 generations on1descendant
- K113709Megabeam Fiber Optic Delivery System with Additional Tips & HandpieceBiolitec Medical Devices, Inc. · 2012 · cites it directly0descendants
- K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009 · 3 generations on0descendants
- K060905Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1Iridex Corp · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946336 | Megabeam Fiber Optic Delivery System | Hogan & Hartson | 1995 | — |
| +1 | K980389 | Megabeam Reusable Fiber Optic Handpiece and Needles | Ceram Optec, Inc. | 1998 | — |
| +2 | K061025 | Accutech Endolite Probe | Accutech Medical Technologies, Inc. | 2006 | — |
| +1 | K113709 | Megabeam Fiber Optic Delivery System with Additional Tips & Handpiece | Biolitec Medical Devices, Inc. | 2012 | — |
| +3 | K090281 | Accutech Family of Powerflex Laser Delivery Devices | Accutech Medical Technologies, Inc. | 2009 | — |
| +2 | K060905 | Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1 | Iridex Corp | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K980389 (Ceram Optec, Inc., 1998) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K946336 · printed Nov 4, 2026
Cite this page
510(k) Report. “K946336: 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/K946336
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026