Hironic Co., Ltd.

Country / Region:Korea, Republic of (KR)Website:hironic.com

510(k) submissions

Latest clearance

2026-04-06

Product codes

GEI, GEX

Cited as predicate

Product areas

FDA product code distribution

4 total

Showing 1–4

K number	Device name	Product code	Class	Decision
K260397	SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)	GEI	Class 2	2026-04-06
K251334	NEW DOUBLO 2.0	GEI	Class 2	2025-09-29
K201773	PICOHI	GEX	Class 2	2021-10-19
K173676	A-FIT	GEX	Class 2	2018-09-14

Companies whose devices this company cited as predicates

1 manufacturers

Companies that cited this company's devices as predicates

3 manufacturers