510(k) · Cleared
ClearedEL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model IA-2000-S, Lightwave Ablator, Model IA-
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 25, 2009 as substantially equivalent to K050923 (Conmed Linvatec, 2005) and 1 other predicate after a 110-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Feb 25, 2009
- Review
- 110 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K011083 (2001). 30 ancestors in all, the oldest K944992 (1995). No later device cites it as a predicate yet.
- Root · 11 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 7 generations between
- 3 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 2 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 1 generation backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- This deviceK083281 EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction…Linvatec Corp. · 2009
Show all 11 generations
- Root · 11 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 10 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 9 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 8 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 7 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 6 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 5 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 4 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 3 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 2 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 1 generation backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- This deviceK083281 EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction…Linvatec Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −10 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −9 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −8 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −7 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −6 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −5 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −4 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −3 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −2 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −1 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| 0 (this device) | K083281 | EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator… | Linvatec Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K050923 | Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction AblatorSummary page 1…nMed Linvatec LightWave® Integrated Electrode Ablator and LightWave® Integrated Electrode Suction Ablator 5 10(k) # K050923 ArthroCare® ArthroWands® 510(k) # K082323 E. Device Description The ConMed Linvatec Light… | 2005 |
| * | K082323 | Arthrocare ArthrowandsSummary page 1…ted Electrode Suction Ablator 5 10(k) # K050923 ArthroCare® ArthroWands® 510(k) # K082323 E. Device Description The ConMed Linvatec LightWave®Ablators are comprised of a range of non- suction and suction devices,… | 2008 |
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 8 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 3 of the 30 ancestors have a recall of any class.
- 1 other device also cites its predicate K050923.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The ConMed Linvatec Lightwave® Ablators are intended to be used for electrosurgical cutting and coagulation in arthroscopic procedures, using a conductive fluid environment. Additionally, the suction/aspiration versions of these devices have the capability for suctioning irrigation fluids.
Electrosurgical cutting and coagulation may be performed in various joints such as the shoulder, ankle, wrist, elbow, knee, and hip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083281: EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model IA-2000-S, Lightwave Ablator, Model IA-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083281
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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