510(k) · Cleared
ClearedMegabeam Reusable Fiber Optic Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolitec Medical Devices, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 13, 2012 as substantially equivalent to K980838 (Ceram Optec, Inc., 1998) after an 89-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Mar 13, 2012
- Review
- 89 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902990 (1990). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK902990 Coherent Holmium:Yag Surgical LaserCoherent Medical Division · 1990
- 2 generations backK960413 Coherent Slimline Single Lumen Aspiration Needle KitLumenis, Inc. · 1996
- 1 generation backK980838 Reusable Megabeam Fiber Optic Delivery SystemCeram Optec, Inc. · 1998
- This deviceK113688 Megabeam Reusable Fiber Optic Delivery SystemBiolitec Medical Devices, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902990 | Coherent Holmium:Yag Surgical Laser | Coherent Medical Division | 1990 | — |
| −2 | K960413 | Coherent Slimline Single Lumen Aspiration Needle Kit | Lumenis, Inc. | 1996 | — |
| −1 | K980838 | Reusable Megabeam Fiber Optic Delivery System | Ceram Optec, Inc. | 1998 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K980838 | Reusable Megabeam Fiber Optic Delivery SystemSummary page 1…c. 515 Shaker Road East Longmeadow, Massachusetts 01028 Classification Name Surgical laser accessory Predicate Devices MegaBeami Reusable Fiber Optic Delivery System, (K980838) Intended Use/Indication for Use TheMegaBeam Reusable Fiber Optic Delivery System is intended for use as an accessory to any sur… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The MegaBeam Reusable Fiber Optic Delivery System is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113688: Megabeam Reusable Fiber Optic Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113688
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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