# K260397: SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)

- Pathway: 510(k) (Traditional)
- Applicant: Hironic Co., Ltd.
- Decided: Apr 6, 2026 after 59 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: 10 generations back to K933002 (1994). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The device is used in the removal and destruction of skin lesions and coagulation of tissue.

Source page: https://510kreport.com/device/K260397
Methodology: https://510kreport.com/methodology