510(k) · Cleared
ClearedFlexguide Ultra Beampath Robotic Fiber Conduit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omniguide, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 25, 2014 as substantially equivalent to K081939 (Omniguide, Inc., 2008) and 3 other predicates after a 223-day review. Its family tree reaches back 8 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 25, 2014
- Review
- 223 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K953074 (1995). 33 ancestors in all, the oldest K844002 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
- 7 generations backK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
- 6 generations backK992472 Sureguide CO2 Laser Beam Delivery SystemClinicon Corp. · 1999
- 5 generations backK014048 Clinicon Universal Waveguide Handpiece and Fiber TipsClinicon Corp. · 2002
- 4 generations backK050541 Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005
- 3 generations backK070157 Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007 · Recalled
- 2 generations backK073313 Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc. · 2008
- 1 generation backK093451 Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low…Omniguide, Inc. · 2009
- This deviceK140378 Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK170777 Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK202880 J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K953074 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1995 | — |
| −7 | K960475 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1996 | — |
| −6 | K992472 | Sureguide CO2 Laser Beam Delivery System | Clinicon Corp. | 1999 | — |
| −5 | K014048 | Clinicon Universal Waveguide Handpiece and Fiber Tips | Clinicon Corp. | 2002 | — |
| −4 | K050541 | Omniguide Beampath CO2 Mark I Laser Beam Delivery | Omniguide Communications, Inc. | 2005 | — |
| −3 | K070157 | Omniguide Beam Path CO2 Mark Iii Waveguide Fiber | Omniguide, Inc. | 2007 | 1 |
| −2 | K073313 | Mark Iii Waveguide Fiber with Low Profile Tip | Omniguide, Inc. | 2008 | — |
| −1 | K093451 | Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss Tip | Omniguide, Inc. | 2009 | — |
| 0 (this device) | K140378 | Flexguide Ultra Beampath Robotic Fiber Conduit | Omniguide, Inc. | 2014 | — |
| +1 | K170777 | Bovie J-Plasma Precise FLEX Handpiece | Bovie Medical Corporation | 2017 | — |
| +2 | K202880 | J-Plasma Precise FLEX Handpiece | Apyx Medical Corporation (Formerly Bovie Medical Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K081939 | Omniguide Beampath Fiber Optic Handpiece System and Sterilization TraySummary page 4…Handpiece: See Tables 1 & 2 OmniGuide, Inc. OmniGuide BeamPath Fiber Optic Handpiece System & Sterilization Tray K081939 OmniGuide, Inc. 1 OmniGuide Laser System with Fl… | 2008 |
| * | K093251 | Omniguide Beampath Fels 25A CO2 Laser SystemSummary page 5…with FlexGuide™ Ultra Laser: No Changes OmniGuide, Inc. OmniGuide BeamPath FELS 25A CO2 Laser System K093251 Fibers: No Changes, see Table 1. OmniGuide, Inc. OmniGuide BeamPath CO2 Mark III WaveGui… | 2009 |
| * | K070157 | Omniguide Beam Path CO2 Mark Iii Waveguide FiberSummary page 5…K093251 Fibers: No Changes, see Table 1. OmniGuide, Inc. OmniGuide BeamPath CO2 Mark III WaveGuide Fiber K070157 OmniGuide, Inc. OmniGuide BeamPath CO2 Mark III WaveGuide Fiber w/Low Loss Tip K093451… | 2007 |
| * | K093451 | Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss TipSummary page 5…CO2 Mark III WaveGuide Fiber K070157 OmniGuide, Inc. OmniGuide BeamPath CO2 Mark III WaveGuide Fiber w/Low Loss Tip K093451 OmniGuide, Inc. 2 OmniGuide Laser System with FlexGuide™ Ultra… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170777 | Bovie J-Plasma Precise FLEX Handpiece | 2017 | 1 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 33 ancestors has a recall of any class.
- Of its descendants, K170777 (Bovie Medical Corporation, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K081939.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece, is indicated for use to enable the surgeon to perform incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. This system is intended for use with a grasper in the following medical specialties: general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, urologic surgical procedures, otorhinolaryngology surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140378: Flexguide Ultra Beampath Robotic Fiber Conduit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140378
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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