# K050923: Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction Ablator

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Linvatec
- Decided: May 18, 2005 after 35 days
- Product code: JOS (Electrode, Electrosurgical)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K944992 (1995). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993885: Ultrablator Electrode, Linvatec Corp. (2000) Summary page 2.
- K002422: Varpr 3.5MM 90 Suction Electrode for Use with Vapr System, Mitek Products (2000) Summary page 3.
- K021299: Conmed Heatwave Hand-Controlled Eletrode, Conmedcorp (2002) Summary page 2.
- K030720: Ultrablator Electrode, Linvatec Corp. (2003) Summary page 2.
- K983652: Ablator Electrode, Linvatec Corp. (1999) Summary page 2.

## Most influential descendants
- K083281: EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model IA-2000-S, Lightwave Ablator, Model IA- (2009), 0 descendants of its own
- K052692: Suretek Medical Reprocessed Electrosurgical Electrodes (2006), 0 descendants of its own

## Recalls of this device
- Jul 31, 2009 · Not classified · Z-2051-2009: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K050923
Methodology: https://510kreport.com/methodology