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Hironic Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)April 6, 2026
K251334NEW DOUBLO 2.0September 29, 2025
K241099Plasonic (Plasonic)November 8, 2024
K233123SILKROJune 24, 2024
K210084SILKROJune 3, 2022
K201773PICOHIOctober 19, 2021
K192970SLIMUSDecember 1, 2020
K173676A-FITSeptember 14, 2018