# K241099: Plasonic (Plasonic)

- Pathway: 510(k) (Traditional)
- Applicant: Hironic Co., Ltd.
- Decided: Nov 8, 2024 after 200 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: 9 generations back to K933002 (1994). 31 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223222: Plasma IQ, Neauvia North America, Inc. (2023) Summary page 5.
- K230472: Sonopuls 190, Enraf-Nonius, B.V. (2023) Summary page 5.
- K161628: JAS Pulse (TM) Ultrasonic Therapy, Bonutti Research, Inc. (2016) Summary page 5.

## Most influential descendants
- K260397: SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) (2026), 0 descendants of its own
- K251334: New Doublo 2.0 (2025), 0 descendants of its own

## Indications for use
The PLASONIC with PLAPASS handpiece (Radiofrequency) is intended for the removal and destruction of skin lesions and coagulation of tissue. The PLASOINC with SONOPASS handpiece (Ultrasound) is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques.

Source page: https://510kreport.com/device/K241099
Methodology: https://510kreport.com/methodology