510(k) · Cleared
ClearedMark Iii Waveguide Fiber with Low Profile Tip
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 Jan 2, 2008 as substantially equivalent to K050541 (Omniguide Communications, Inc., 2005) and 1 other predicate after a 37-day review. Its family tree reaches back 6 generations to 1995. 5 later devices descend from it.
- Decided
- Jan 2, 2008
- Review
- 37 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). 5 later devices descend from it, 2 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 backK070157 Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007 · Recalled
- This deviceK073313 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 · 2 generations on · 2 of its ownK140378 Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK170777 Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation · 2017
- Descendant · cites it directly · 0 of its ownK203241 OmniGuide BeamPath OTO-U FiberOmniguide, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK202880 J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation · 2021
Most influential descendants
Showing 5 of 5 · See all- 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 · 2 generations on2descendants
- K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation · 2017 · 3 generations on1descendant
- K203241OmniGuide BeamPath OTO-U FiberOmniguide, Inc. · 2021 · cites it directly0descendants
- K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation · 2021 · 4 generations on0descendants
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 | K070157 | Omniguide Beam Path CO2 Mark Iii Waveguide Fiber | Omniguide, Inc. | 2007 | 1 |
| 0 (this device) | 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 | — |
| +2 | K140378 | Flexguide Ultra Beampath Robotic Fiber Conduit | Omniguide, Inc. | 2014 | — |
| +3 | K170777 | Bovie J-Plasma Precise FLEX Handpiece | Bovie Medical Corporation | 2017 | — |
| +1 | K203241 | OmniGuide BeamPath OTO-U Fiber | Omniguide, Inc. | 2021 | — |
| +4 | 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 |
|---|---|---|
| 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 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…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 K070157, OmniGuide Beam Path C02 Mark III WaveGuide Fiber… | 2005 |
| * | K070157 | Omniguide Beam Path CO2 Mark Iii Waveguide FiberSummary page 1…surgery and in dermatology. Substantial Equivalence Claimed To: K050541, OmniGuide Beam Path CO 2 Mark I Laser Beam Delivery System K070157, OmniGuide Beam Path C02 Mark III WaveGuide Fiber Page 14 De… | 2007 |
What descends from it? (5)
2 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)
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 13 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K093451 (Omniguide, Inc., 2009) has gone furthest, with 4 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. 2008, 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 Beam Path C02 Mark III WaveGuide Fiber with Low Profile Tip 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…
Read the full statement (120 words)
The OmniGuide Beam Path C02 Mark III WaveGuide Fiber with Low Profile Tip 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/K073313 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073313: Mark Iii Waveguide Fiber with Low Profile Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073313
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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