510(k) · Cleared
ClearedMegabeam Fiber Optic Delivery System with Additional Tips & Handpiece
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 Jan 20, 2012 as substantially equivalent to K946336 (Hogan & Hartson, 1995) and 2 other predicates after a 32-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jan 20, 2012
- Review
- 32 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K923953 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK923953 MegabeamCeram Optec, Inc. · 1992
- This deviceK113709 Megabeam Fiber Optic Delivery System with Additional Tips & HandpieceBiolitec Medical Devices, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923953 | Megabeam | Ceram Optec, Inc. | 1992 | — |
| 0 (this device) | K113709 | Megabeam Fiber Optic Delivery System with Additional Tips & Handpiece | Biolitec Medical Devices, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K946336 | Megabeam Fiber Optic Delivery SystemSummary page 1…ongmeadow, Massachusetts 01028 Classification Name Surgical laser accessory Predicate Devices MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece, (K(946336, K(923953 and K(943445) Intended Use/Indication for Use The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiec… | 1995 |
| * | K923953 | MegabeamSummary page 1…Massachusetts 01028 Classification Name Surgical laser accessory Predicate Devices MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece, (K(946336, K(923953 and K(943445) Intended Use/Indication for Use The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is inten… | 1992 |
| * | K943445 | Megabeam Fiber Optic Delivery SystemSummary page 1…s 01028 Classification Name Surgical laser accessory Predicate Devices MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece, (K(946336, K(923953 and K(943445) Intended Use/Indication for Use The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is intended for use a… | 1994 |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K946336.
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 Fiber Optic Delivery System with Additional Tips & Handpiece 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/K113709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113709: Megabeam Fiber Optic Delivery System with Additional Tips & Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113709
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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