# K211000: Acutron

- Pathway: 510(k) (Traditional)
- Applicant: Ilooda Co,., Ltd.
- Decided: Jun 9, 2022 after 433 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: 21 generations back to K943450 (1995). 283 ancestors in all.
No later device cites it as a predicate yet.
0 of 284 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182355: Secret RF Smartcure Applicator with electrodes, Ilooda Co,., Ltd. (2019) Summary page 5.

## Indications for use
ACUTRON is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

Source page: https://510kreport.com/device/K211000
Methodology: https://510kreport.com/methodology