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 & R Investments, LLC Dba Laser Engineering · GEX Powered Laser Surgical Instrument
Cleared on Jul 30, 2021 as substantially equivalent to K112166 (W and R Investments Dba Laser Engineering, 2011) and 1 other predicate after a 52-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jul 30, 2021
- Review
- 52 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K953074 (1995). 19 ancestors in all, the oldest K894762 (1989). No later device cites it as a predicate yet.
- Root · 7 generations backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
- 6 generations backK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
- 5 generations backK992472 Sureguide CO2 Laser Beam Delivery SystemClinicon Corp. · 1999
- 4 generations backK014048 Clinicon Universal Waveguide Handpiece and Fiber TipsClinicon Corp. · 2002
- 3 generations backK050541 Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005
- 2 generations backK070157 Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007 · Recalled
- 1 generation backK112166 Ultralase Flexible CO2 Laser WaveguideW and R Investments Dba Laser Engineering · 2011
- This deviceK211761 UltraLase Flexible CO2 Laser WaveguideW & R Investments, LLC Dba Laser Engineering · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K953074 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1995 | — |
| −6 | K960475 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1996 | — |
| −5 | K992472 | Sureguide CO2 Laser Beam Delivery System | Clinicon Corp. | 1999 | — |
| −4 | K014048 | Clinicon Universal Waveguide Handpiece and Fiber Tips | Clinicon Corp. | 2002 | — |
| −3 | K050541 | Omniguide Beampath CO2 Mark I Laser Beam Delivery | Omniguide Communications, Inc. | 2005 | — |
| −2 | K070157 | Omniguide Beam Path CO2 Mark Iii Waveguide Fiber | Omniguide, Inc. | 2007 | 1 |
| −1 | K112166 | Ultralase Flexible CO2 Laser Waveguide | W and R Investments Dba Laser Engineering | 2011 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K112166 | Ultralase Flexible CO2 Laser WaveguideSummary page 4…cate Devices: The UltraLase Flexible CO2 Laser Waveguides (K211761) Model HWG505 and HWG305 are modifications of the currently marketed devices (K112166) Model HWG500-2.0-3.0 and the HWG300-2.0-3.0 respectively. Reference device: In addition, the UltraLase Flexib… | 2011 |
| * | K100384 | Fiberlase C02 Laser WaveguideSummary page 4…ely. Reference device: In addition, the UltraLase Flexible CO2 Laser Waveguide is substantially equivalent to the FiberLase CO2 Laser Waveguide (K100384) manufactured by Lumenis, Ltd. Device Description: The UltraLase Flexible CO2 Laser Waveguides are laser del… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 19 ancestors has a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211761 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211761: UltraLase Flexible CO2 Laser Waveguide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211761
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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