# K210084: Silkro

- Pathway: 510(k) (Traditional)
- Applicant: Hironic Co., Ltd.
- Decided: Jun 3, 2022 after 507 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: 20 generations back to K943450 (1995). 282 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 286 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170325: Secret RF, Ilooda Co,., Ltd. (2017) Summary page 4.

## Most influential descendants
- K233123: Silkro (2024), 1 descendant of its own
- K251334: New Doublo 2.0 (2025), 0 descendants of its own
- K233120: CWM-930S, Fixer DV9 (2024), 0 descendants of its own

## Indications for use
This device is intended for use in dermatologic and general surgical procedures for electro-coagulation.

Source page: https://510kreport.com/device/K210084
Methodology: https://510kreport.com/methodology