Hironic Co., Ltd. · Class II · Cleared Apr 6, 2026
| K-number | K260397 |
| Device name | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) |
| Applicant | Hironic Co., Ltd. |
| Product code | GEI |
| Device class | Class II |
| Decision date | Apr 6, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
The SYNERJET PRO, InPhiuse, and WOWJET devices (all model SP-1002) are electrosurgical cutting and coagulation devices used for removal and destruction of skin lesions and tissue coagulation. The device consists of a main unit, LCD touch screen, handpiece, foot switch, accessories, and power cable, and is intended for prescription use in adults.
The device has the same or similar technological characteristics as the predicate device, including mode of operation, output, frequency, and electrical safety standards. It uses radiofrequency technology delivered through a handpiece with various tip and brush applicators.
Non-clinical testing evaluated coagulation and temperature increase in ex vivo tissue. The test confirmed that application of the device to target regions achieved intended temperature increase and coagulation area under various power output conditions.
The device's indication for use (removal and destruction of skin lesions and coagulation of tissue) is present within the predicate PLASONIC device's indications, specifically matching the radiofrequency PLAPASS handpiece function. The device shares identical technological characteristics and safety standards with the predicate.
View the full FDA submission: accessdata.fda.gov