Hironic Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: SYNERJET PRO (SP-1002), NEW DOUBLO 2.0, Plasonic (Plasonic)
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hironic Co., Ltd. General & Plastic Surgery ✕
8 devices
Cleared
Apr 06, 2026
SYNERJET PRO (SP-1002)
General & Plastic Surgery
59d
Cleared
Sep 29, 2025
NEW DOUBLO 2.0
General & Plastic Surgery
152d
Cleared
Nov 08, 2024
Plasonic (Plasonic)
General & Plastic Surgery
200d
Cleared
Jun 24, 2024
SILKRO
General & Plastic Surgery
271d
Cleared
Jun 03, 2022
SILKRO
General & Plastic Surgery
507d
Cleared
Oct 19, 2021
PICOHI
General & Plastic Surgery
477d
Cleared
Dec 01, 2020
SLIMUS
General & Plastic Surgery
405d
Cleared
Sep 14, 2018
A-FIT
General & Plastic Surgery
288d