# K220138: Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP

- Pathway: 510(k) (Traditional)
- Applicant: Led Spa
- Decided: Oct 5, 2022 after 260 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
SURTRON model devices (80D, 160, 200, FLASH 160 HF, 400 HP) are ElectroSurgical Units including monopolar and bipolar technology (excepts SURTRON 80D which delivers monopolar technology only). They are intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.

Source page: https://510kreport.com/device/K220138
Methodology: https://510kreport.com/methodology