# K134036: Wavetronic 5000 Digital HF Surgical Unit

- Pathway: 510(k) (Traditional)
- Applicant: Loktal Medical Electronics Ind. Com. Ltda- Epp
- Decided: Oct 8, 2015 after 646 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: 12 generations back to K943450 (1995). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082834: Ellman International Non-Ablative Technique for Surgitron  Iec, Ellman Int'L, Inc. (2009) Summary page 4.
- K051956: DR. Oppel ST-501, Sometech Incorporated (2005) Summary page 4.

## Indications for use
The Loktal Medical Electronics ind. E com. Ltda EPP - Wavetronic 5000 Digital HF Surgical Unit is intended for resection, ablation, excision of soft tissue, coagulation, and desiccation of soft tissue in patients requiring surgery.

Source page: https://510kreport.com/device/K134036
Methodology: https://510kreport.com/methodology