# K061258: Trabectome High Frequency Generator/LP

- Pathway: 510(k) (Traditional)
- Applicant: Neomedix Corp.
- Decided: May 18, 2006 after 13 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955681 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955681: Aaron 800 High Frequency Desiccator/Handpiece, Geiger Instrument Co., Inc. (1996) Summary page 1.

## Indications for use
The TrabectomeTM High Frequency Generator/LP is for use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue.

Source page: https://510kreport.com/device/K061258
Methodology: https://510kreport.com/methodology