DeviceClearance

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)— 510(k) K260397

Substantially Equivalent

Hironic Co., Ltd.

FDA 510(k) clearance K260397 for SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002), Substantially Equivalent on 2026-04-06. Applicant: Hironic Co., Ltd.. Device class: 2.

Summary

Hironic's record names three products, SYNERJET PRO, InPhiuse, and WOWJET, each listed with the same model number, SP-1002. All three are filed under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Class II, 21 CFR 878.4400. It came in as a Traditional 510(k), and General and Plastic Surgery is both the classification panel and the review panel.

Hironic filed from Yongin-Si, South Korea. Review took 59 calendar days (February 6 to April 6, 2026).

Clearance details

Applicant
Hironic Co., Ltd.
Product code
Product code GEI
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Yongin-Si, KR
Download summary PDFView on FDA.gov ↗

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More clearances from Hironic Co., Ltd.

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Adverse events under product code GEI

product code GEI
Death
133
Injury
7,585
Malfunction
35,808
Other
44
Total
43,570

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.