# K251334: New Doublo 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Hironic Co., Ltd.
- Decided: Sep 29, 2025 after 152 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: 22 generations back to K943450 (1995). 317 ancestors in all.
No later device cites it as a predicate yet.
0 of 318 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233123: Silkro, Hironic Co., Ltd. (2024) Summary page 5.
- K241099: Plasonic (Plasonic), Hironic Co., Ltd. (2024) Summary page 5.

## Indications for use
The NEW DOUBLO 2.0 with RM and RM(B) handpiece is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The NEW DOUBLO 2.0 with PS handpiece is intended for the removal and destruction of skin lesions and coagulation of tissue.

Source page: https://510kreport.com/device/K251334
Methodology: https://510kreport.com/methodology