# K233123: Silkro

- Pathway: 510(k) (Traditional)
- Applicant: Hironic Co., Ltd.
- Decided: Jun 24, 2024 after 271 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). 299 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 301 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210084: Silkro, Hironic Co., Ltd. (2022) Summary page 4.
- K201738: SubNovii Advanced Plasma Technology, Cartessa Aesthetics (2020) Summary page 4.

## Most influential descendants
- K251334: New Doublo 2.0 (2025), 0 descendants of its own

## Indications for use
The SILKRO with RM, RN, RC, RV, PS handpieces is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The SILKRO with RN handpieces is intended for the removal and destruction of skin lesions and coagulation of tissue.

Source page: https://510kreport.com/device/K233123
Methodology: https://510kreport.com/methodology