SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)— 510(k) K260387

Name: FDA 510(k) clearance K260387
Creator: U.S. Food and Drug Administration
Published: 2026-08-31

Substantially Equivalent

Hironic Co., Ltd.

FDA 510(k) clearance K260387 for SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003), Substantially Equivalent on 2026-08-31. Applicant: Hironic Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hironic Co., Ltd.
Product code: Code NFO
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2026-02-06
Decision date: 2026-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Hironic Co., Ltd.

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K260397 — SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)2026-04-06
K251334 — NEW DOUBLO 2.02025-09-29
K241099 — Plasonic (Plasonic)2024-11-08
K233123 — SILKRO2024-06-24
K210084 — SILKRO2022-06-03

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