510(k) · Cleared
Recalled · 2009Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction Ablator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec · JOS Electrode, Electrosurgical
Cleared on May 18, 2005 as substantially equivalent to K993885 (Linvatec Corp., 2000) and 4 other predicates after a 35-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- May 18, 2005
- Review
- 35 days
- Class
- Class II
- Product code
- JOS
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 3 generations to K944992 (1995). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK944992 ElectrodesLinvatec Corp. · 1995
- 2 generations backK993885 Ultrablator ElectrodeLinvatec Corp. · 2000
- 1 generation backK030720 Ultrablator ElectrodeLinvatec Corp. · 2003
- This deviceK050923 Lightwave Integrated Electrode Ablator and Light Wave Integrated…Conmed Linvatec · 2005
- Descendant · cites it directly · 0 of its ownK083281 EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction…Linvatec Corp. · 2009
- Descendant · cites it directly · 0 of its ownK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944992 | Electrodes | Linvatec Corp. | 1995 | — |
| −2 | K993885 | Ultrablator Electrode | Linvatec Corp. | 2000 | — |
| −1 | K030720 | Ultrablator Electrode | Linvatec Corp. | 2003 | — |
| 0 (this device) | K050923 | Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode… | Conmed Linvatec | 2005 | — |
| +1 | K083281 | EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator… | Linvatec Corp. | 2009 | — |
| +1 | K052692 | Suretek Medical Reprocessed Electrosurgical Electrodes | Suretek Medical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 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 JOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K993885 | Ultrablator ElectrodeSummary page 2…an LightWave' Integrated ElectrodeSuto 5 10(k)# o• t April 5, 2005 Page 2 of 3 D. Predicate/Legally Marketed Devices K993885 - UltrAblator, Linvatec: Corporation K(002422 - VAPRTm 3.5mm 90' Suction Electrode for use with the VAPRTM Syst… | 2000 |
| * | K002422 | Varpr 3.5MM 90 Suction Electrode for Use with Vapr SystemSummary page 3…ice subject to this application submission is attached. Substantially Equivalent Predicate Marketed Devices: K993885 - UltrAblator, Linvatec Corporation K002422 - VAPRTM 3.5mm 90' Suction Electrode for use with the VAPRTM System, Mitek Products K021299 - Heatwave Ha… | 2000 |
| * | K021299 | Conmed Heatwave Hand-Controlled EletrodeSummary page 2…Corporation K(002422 - VAPRTm 3.5mm 90' Suction Electrode for use with the VAPRTM System, Mitek Products K02 1299 - Heatwave Hand-Controlled Electrode, ConMed Corporation K(030720 - UltrAblator, Linvatec Corporation… | 2002 |
| * | K030720 | Ultrablator ElectrodeSummary page 2…Device Description The ConMed/Linvatec LightWave TM Integrated Electrode Ablators are a modificati on of the currently marketed 3.2 mm UltrAblator electrode (Linvatec, K030720) and a Switch Pencil control handle (Linvatec, K983652) integrated into one device. One version incorporates hand- controlled but… | 2003 |
| * | K983652 | Ablator ElectrodeSummary page 2…ntegrated Electrode Ablators are a modificati on of the currently marketed 3.2 mm UltrAblator electrode (Linvatec, K030720) and a Switch Pencil control handle (Linvatec, K983652) integrated into one device. One version incorporates hand- controlled buttons to actuate the "cut" and "coag" functions of the e… | 1999 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2009 | Not classified | Z-2051-2009 | Device Design | ConMed Linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/patients suffering burns. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K083281 (Linvatec Corp., 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K993885.
How does its category compare?
All JOS devicesJOS Electrode, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JOS
Too few JOS 510(k)s in any year since 2007 to give a median.
Recalls per year · JOS
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOS
6in 2025
MAUDE reports naming product code JOS, 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 | 0 | — | 0 | 29 |
| 2008 | 0 | — | 1 | 37 |
| 2009 | 0 | — | 0 | 62 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 2 | 7 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 2 | 17 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ConMed/Linvatec LightWave"' Integrated Electrode Ablators are intended to be used for electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures in a conductive fluid environment. Additionally, the suction/aspiration version also has capability for suctioning irrigation fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050923 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050923: Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction Ablator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050923
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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