510(k) · Cleared
Recalled · Class II · 2012Omniguide Beam Path CO2 Mark Iii 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 Feb 1, 2007 as substantially equivalent to K050541 (Omniguide Communications, Inc., 2005) after a 15-day review. Its family tree reaches back 5 generations to 1995. 8 later devices descend from it. It has been recalled once.
- Decided
- Feb 1, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953074 (1995). 16 ancestors in all, the oldest K894762 (1989). 8 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
- 4 generations backK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
- 3 generations backK992472 Sureguide CO2 Laser Beam Delivery SystemClinicon Corp. · 1999
- 2 generations backK014048 Clinicon Universal Waveguide Handpiece and Fiber TipsClinicon Corp. · 2002
- 1 generation backK050541 Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005
- This deviceK070157 Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK073313 Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK093451 Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low…Omniguide, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK140378 Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK170777 Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation · 2017
- Descendant · cites it directly · 1 of its ownK112166 Ultralase Flexible CO2 Laser WaveguideW and R Investments Dba Laser Engineering · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K073313Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc. · 2008 · cites it directly5descendants
- K093451Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss TipOmniguide, Inc. · 2009 · cites it directly4descendants
- K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 2014 · cites it directly2descendants
- K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation · 2017 · 2 generations on1descendant
- K112166Ultralase Flexible CO2 Laser WaveguideW and R Investments Dba Laser Engineering · 2011 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953074 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1995 | — |
| −4 | K960475 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1996 | — |
| −3 | K992472 | Sureguide CO2 Laser Beam Delivery System | Clinicon Corp. | 1999 | — |
| −2 | K014048 | Clinicon Universal Waveguide Handpiece and Fiber Tips | Clinicon Corp. | 2002 | — |
| −1 | K050541 | Omniguide Beampath CO2 Mark I Laser Beam Delivery | Omniguide Communications, Inc. | 2005 | — |
| 0 (this device) | K070157 | Omniguide Beam Path CO2 Mark Iii Waveguide Fiber | Omniguide, Inc. | 2007 | — |
| +1 | 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 | — |
| +1 | K140378 | Flexguide Ultra Beampath Robotic Fiber Conduit | Omniguide, Inc. | 2014 | — |
| +2 | K170777 | Bovie J-Plasma Precise FLEX Handpiece | Bovie Medical Corporation | 2017 | — |
| +1 | K112166 | Ultralase Flexible CO2 Laser Waveguide | W and R Investments Dba Laser Engineering | 2011 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 3 | 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 |
|---|---|---|---|
| * | K050541 | Omniguide Beampath CO2 Mark I Laser Beam DeliverySummary page 1…on Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Substantial Equivalence Claimed To: K050541, OmniGuide Beam Path CO 2 Mark I Laser Beam Delivery System Page 15 Descripti… | 2005 |
What descends from it? (8)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2012 | Class II | Z-0453-2013 | Process control | Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K073313 (Omniguide, Inc., 2008) has gone furthest, with 5 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. 2007, 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 Mark Ill WaveGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic…
Read the full statement (113 words)
The OmniGuide Mark Ill WaveGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy.
The indications for use for which the delivery system is used for 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/K070157 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070157: Omniguide Beam Path CO2 Mark Iii Waveguide Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070157
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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