510(k) · Cleared
ClearedOmniguide Zero Flow ZF-T 150 Waveguide Fiber
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 Nov 29, 2006 as substantially equivalent to K050541 (Omniguide Communications, Inc., 2005) and 1 other predicate after a 44-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Nov 29, 2006
- Review
- 44 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K953074 (1995). 17 ancestors in all, the oldest K894762 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
- 5 generations backK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
- 4 generations backK992472 Sureguide CO2 Laser Beam Delivery SystemClinicon Corp. · 1999
- 3 generations backK014048 Clinicon Universal Waveguide Handpiece and Fiber TipsClinicon Corp. · 2002
- 2 generations backK050541 Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005
- 1 generation backK061909 Highland Beam Delivery System, Model 3-099-002-00-00Omniguide, Inc. · 2006
- This deviceK063141 Omniguide Zero Flow ZF-T 150 Waveguide FiberOmniguide, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK070071 Omniguide Zero Flow ZF-T Waveguide FiberOmniguide, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070071Omniguide Zero Flow ZF-T Waveguide FiberOmniguide, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953074 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1995 | — |
| −5 | K960475 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1996 | — |
| −4 | K992472 | Sureguide CO2 Laser Beam Delivery System | Clinicon Corp. | 1999 | — |
| −3 | K014048 | Clinicon Universal Waveguide Handpiece and Fiber Tips | Clinicon Corp. | 2002 | — |
| −2 | K050541 | Omniguide Beampath CO2 Mark I Laser Beam Delivery | Omniguide Communications, Inc. | 2005 | — |
| −1 | K061909 | Highland Beam Delivery System, Model 3-099-002-00-00 | Omniguide, Inc. | 2006 | — |
| 0 (this device) | K063141 | Omniguide Zero Flow ZF-T 150 Waveguide Fiber | Omniguide, Inc. | 2006 | — |
| +1 | K070071 | Omniguide Zero Flow ZF-T Waveguide Fiber | Omniguide, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (2)
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 |
|---|---|---|---|
| * | K050541 | Omniguide Beampath CO2 Mark I Laser Beam DeliverySummary page 1…Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Substantial Equivalence Claimed To: 1K050541, OmnniGuide Beam Path CO 2 Mark I Laser Beam Delivery System 1(06 1909, OmniGuide Highland Ream Delivery System… | 2005 |
| * | K061909 | Highland Beam Delivery System, Model 3-099-002-00-00 | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070071 | Omniguide Zero Flow ZF-T Waveguide Fiber | 2007 | 0 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K070071 (Omniguide, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K050541.
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 | — |
What is it indicated for?
The OmniGuide Zero Flow ZF-T 150 WaveGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral / maxillofacial surgery, dentistry, dermatology, endoscopic and open surgical procedures related to gynecology, otorhinolaryngology, gastroenterology, neurosurgery, pulmonary surgery for surgical and aesthetic applications.
The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063141: Omniguide Zero Flow ZF-T 150 Waveguide Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063141
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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