510(k) · Cleared
ClearedOmniguide Beampath CO2 Mark I Laser Beam Delivery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omniguide Communications, Inc. · HQF Laser, Ophthalmic
Cleared on May 9, 2005 as substantially equivalent to K992472 (Clinicon Corp., 1999) and 7 other predicates after a 68-day review. Its family tree reaches back 4 generations to 1995. 14 later devices descend from it.
- Decided
- May 9, 2005
- Review
- 68 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 4 generations to K953074 (1995). 15 ancestors in all, the oldest K894762 (1989). 14 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
- 3 generations backK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
- 2 generations backK992472 Sureguide CO2 Laser Beam Delivery SystemClinicon Corp. · 1999
- 1 generation backK014048 Clinicon Universal Waveguide Handpiece and Fiber TipsClinicon Corp. · 2002
- This deviceK050541 Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK070157 Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007 · Recalled
- Descendant · cites it directly · 5 of its ownK073313 Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc. · 2008
- Descendant · 2 generations on · 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 · cites it directly · 2 of its ownK061909 Highland Beam Delivery System, Model 3-099-002-00-00Omniguide, Inc. · 2006
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K070157Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007 · cites it directly8descendants
- 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 · 2 generations on4descendants
- K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 2014 · 2 generations on2descendants
- K061909Highland Beam Delivery System, Model 3-099-002-00-00Omniguide, Inc. · 2006 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953074 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1995 | — |
| −3 | K960475 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1996 | — |
| −2 | K992472 | Sureguide CO2 Laser Beam Delivery System | Clinicon Corp. | 1999 | — |
| −1 | K014048 | Clinicon Universal Waveguide Handpiece and Fiber Tips | Clinicon Corp. | 2002 | — |
| 0 (this device) | 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 |
| +1 | K073313 | Mark Iii Waveguide Fiber with Low Profile Tip | Omniguide, Inc. | 2008 | — |
| +2 | 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 | — |
| +1 | K061909 | Highland Beam Delivery System, Model 3-099-002-00-00 | Omniguide, Inc. | 2006 | — |
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 |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 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 HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K992472 | Sureguide CO2 Laser Beam Delivery SystemSummary page 1…al instrument for use in general and plastic surgery and in dermatology. Substantial Equivalence Claimed To: K992472 Clinicorn SureGuide CO 2 Laser Beam Delivery System. K014048 Cl… | 1999 |
| * | K014048 | Clinicon Universal Waveguide Handpiece and Fiber TipsSummary page 1…aimed To: K992472 Clinicorn SureGuide CO 2 Laser Beam Delivery System. K014048 Clinicon Universal WaveGuide Handpiece and Fiber Tips K924664 S… | 2002 |
| * | K924664 | Surgilase Fiberlase CO2 Laser WaveguideSummary page 1…System. K014048 Clinicon Universal WaveGuide Handpiece and Fiber Tips K924664 Surgilase Fiberlase CO 2 Laserwave Guide K92 1671 Surgilase Fiberlase V CO 2 Laser… | 1993 |
| * | K921671 | Surgilase Fiberlase VCO2 Laser WaveguideSummary page 1…Handpiece and Fiber Tips K924664 Surgilase Fiberlase CO 2 Laserwave Guide K92 1671 Surgilase Fiberlase V CO 2 Laser Waveguide K896478 Luxar LX-20… | 1992 |
| * | K896478 | Luxar Model LX-20 Minilase CO2 LaserSummary page 1…2 Laserwave Guide K92 1671 Surgilase Fiberlase V CO 2 Laser Waveguide K896478 Luxar LX-20 Minilase CO 2 Surgical Laser K03 1440 Cynosure Smart CO 2 Medical Laser… | 1990 |
| * | K031440 | Smart CO2 (Smart US 20D, Smart Clinic) Surgical LaserSummary page 1…CO 2 Laser Waveguide K896478 Luxar LX-20 Minilase CO 2 Surgical Laser K03 1440 Cynosure Smart CO 2 Medical Laser System K963 189 ERBE APC 300… | 2003 |
| * | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and…Summary page 1…CO 2 Surgical Laser K03 1440 Cynosure Smart CO 2 Medical Laser System K963 189 ERBE APC 300 Argon Plasma Coagulator K032969 Helica "TC" Laparoscopic Cutting… | 1996 |
| * | K032969 | Helica TC Laparoscopic Cutting and Cauterising (LTC) ProbeSummary page 1…O 2 Medical Laser System K963 189 ERBE APC 300 Argon Plasma Coagulator K032969 Helica "TC" Laparoscopic Cutting and Cauterizing Accessories… | 2004 |
What descends from it? (14)
See all 145 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070157 | Omniguide Beam Path CO2 Mark Iii Waveguide Fiber | 2007 | 8 |
| K073313 | Mark Iii Waveguide Fiber with Low Profile Tip | 2008 | 5 |
| K061909 | Highland Beam Delivery System, Model 3-099-002-00-00 | 2006 | 2 |
| K063141 | Omniguide Zero Flow ZF-T 150 Waveguide Fiber | 2006 | 1 |
| K062423 | Omniguide Beampath Laser Beam Delivery System | 2006 | 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 10 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K070157 (Omniguide, Inc., 2007) has gone furthest, with 8 descendants of its own.
- 5 other devices also cite its predicate K992472.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, 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 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The OmniGuide BeamPath C02 Mark I Laser Beam Delivery System 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/K050541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050541: Omniguide Beampath CO2 Mark I Laser Beam Delivery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050541
Report an extraction error
Are you the manufacturer?
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