Hironic Co., Ltd.

Country / region:Korea, Republic of (KR)

510(k) submissions

2

Latest clearance

2021-10-19

Product codes

1

GEX

Cited as predicate

4

Product areas

FDA product code distribution

510(k) submissions

2 total

K number	Device name	Product code	Class	Decision date
K201773	PICOHI	GEX	Class 2	2021-10-19
K173676	A-FIT	GEX	Class 2	2018-09-14

Company profile

Canonical name: Hironic Co., Ltd.
Country: Korea, Republic of(KR)

Cited predicates

3

K191685
PicoWay Laser System
Candela Corporation
K041242
—
—
Not ingested
K133739
—
—
Not ingested

Hironic Co., Ltd. references 3 predicate/reference devices

Cited as predicate

4

K253342
PICO-K
Speclipse, Inc.
K242207
NOABLE LASER
Daeju Meditech Engineering Co., Ltd.
Not ingested
K241144
Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
Wontech Co., Ltd.
K234104
PICOANDY (Q-Switched Nd:YAG Laser)
Wontech Co., Ltd.

4 submissions cite Hironic Co., Ltd. as a predicate