# K232223: PlaDuo System

- Pathway: 510(k) (Traditional)
- Applicant: ShenB Co., Ltd.
- Decided: Oct 24, 2023 after 90 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). 263 ancestors in all.
No later device cites it as a predicate yet.
0 of 264 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201735: PlaDuo System, ShenB Co., Ltd. (2020) Summary page 5.

## Indications for use
The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Argon handpiece is intended for the removal and destruction of skin lesions and the coagulation of tissue.

Source page: https://510kreport.com/device/K232223
Methodology: https://510kreport.com/methodology