510(k) · Cleared
ClearedUltralase Flexible CO2 Laser Waveguide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W and R Investments Dba Laser Engineering · GEX Powered Laser Surgical Instrument
Cleared on Oct 21, 2011 as substantially equivalent to K100384 (Lumenis, Ltd., 2010) and 2 other predicates after an 85-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Oct 21, 2011
- Review
- 85 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K953074 (1995). 18 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 backK070157 Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007 · Recalled
- This deviceK112166 Ultralase Flexible CO2 Laser WaveguideW and R Investments Dba Laser Engineering · 2011
- Descendant · cites it directly · 0 of its ownK211761 UltraLase Flexible CO2 Laser WaveguideW & R Investments, LLC Dba Laser Engineering · 2021
Most influential descendants
Showing 1 of 1 · See all- K211761UltraLase Flexible CO2 Laser WaveguideW & R Investments, LLC Dba Laser Engineering · 2021 · 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 | K070157 | Omniguide Beam Path CO2 Mark Iii Waveguide Fiber | Omniguide, Inc. | 2007 | 1 |
| 0 (this device) | K112166 | Ultralase Flexible CO2 Laser Waveguide | W and R Investments Dba Laser Engineering | 2011 | — |
| +1 | K211761 | UltraLase Flexible CO2 Laser Waveguide | W & R Investments, LLC Dba Laser Engineering | 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 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K100384 | Fiberlase C02 Laser WaveguideSummary page 1…uivalent to the following devices: Device Manufacturer 510(k) No. FiberL-ase 002 Laser Waveguide Lumenis Ltd K1 00384 SureGuide CO 2 Laser Clinicon Corp. K992472 Beam Delivery System Beam Path CO 2 Mark Ill… | 2010 |
| * | K992472 | Sureguide CO2 Laser Beam Delivery SystemSummary page 1…Manufacturer 510(k) No. FiberL-ase 002 Laser Waveguide Lumenis Ltd K1 00384 SureGuide CO 2 Laser Clinicon Corp. K992472 Beam Delivery System Beam Path CO 2 Mark Ill OmniGuide, Inc. K070157 WaveGuide Fiber… | 1999 |
| * | K070157 | Omniguide Beam Path CO2 Mark Iii Waveguide FiberSummary page 1…K1 00384 SureGuide CO 2 Laser Clinicon Corp. K992472 Beam Delivery System Beam Path CO 2 Mark Ill OmniGuide, Inc. K070157 WaveGuide Fiber 5-1 Device… | 2007 |
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 |
|---|---|---|---|
| K211761 | UltraLase Flexible CO2 Laser Waveguide | 2021 | 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 16 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K211761 (W & R Investments, LLC Dba Laser Engineering, 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K100384.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 UltraLase Flexible CO2 Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues.
The UltraLase Flexible CO2 Laser Waveguide can be used in open surgical procedures and endoscopic procedures.
The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112166: Ultralase Flexible CO2 Laser Waveguide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112166
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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