510(k) · Cleared
ClearedMegabeam Lateral Fire 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 Aug 26, 1994 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.
- Decided
- Aug 26, 1994
- Review
- 36 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 3 citing it directly.
- This deviceK943526 Megabeam Lateral Fire Fiber Optic Delivery SystemCeram Optec, Inc. · 1994
- Descendant · cites it directly · 27 of its ownK112987 Twister Side Fire Optical Fiber Delivery SystemBiolitec Medical Devices, Inc. · 2011
- Descendant · 2 generations on · 25 of its ownK121127 Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM…Cynosure, Inc. · 2012
- Descendant · cites it directly · 24 of its ownK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
- Descendant · cites it directly · 23 of its ownK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
- Descendant · 2 generations on · 13 of its ownK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K112987Twister Side Fire Optical Fiber Delivery SystemBiolitec Medical Devices, Inc. · 2011 · cites it directly27descendants
- K121127Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength LasersCynosure, Inc. · 2012 · 2 generations on25descendants
- K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012 · cites it directly24descendants
- K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc. · 2013 · cites it directly23descendants
- K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943526 | Megabeam Lateral Fire Fiber Optic Delivery System | Ceram Optec, Inc. | 1994 | — |
| +1 | K112987 | Twister Side Fire Optical Fiber Delivery System | Biolitec Medical Devices, Inc. | 2011 | — |
| +2 | K121127 | Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers | Cynosure, Inc. | 2012 | — |
| +1 | K120810 | Fiberoptic Laser Delivery System | Fiberoptic Fabrications, Inc. | 2012 | — |
| +1 | K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers… | Med-Fibers, Inc. | 2013 | — |
| +2 | K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | Laser Peripherals, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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? (29)
See all 293 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, K112987 (Biolitec Medical Devices, Inc., 2011) has gone furthest, with 27 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/K943526 · printed Nov 5, 2026
Cite this page
510(k) Report. “K943526: Megabeam Lateral Fire Fiber Optic Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943526
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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