Ami, Inc.

Country / region:Korea, Republic of (KR)

510(k) submissions

Latest clearance

2024-06-12

Product codes

GEX

Cited as predicate

Product areas

FDA product code distribution

3 total

K number	Device name	Product code	Class	Decision date
K233007	Picosecond Nd:YAG Laser System; PICO LEGEND	GEX	Class 2	2024-06-12
K173359	Fractional CO2 Surgical Laser System	GEX	Class 2	2018-07-05
K172908	Q-Switched Nd:YAG Laser System	GEX	Class 2	2017-12-07

Ami, Inc. references 3 predicate/reference devices

K252447
Picosecond laser device (BMPS4)
Hebei Newangie Technology Co., Ltd.
Not ingested
K252345
Picosecond Laser Device (PF131-BI)
Risu Medical Technology Co., Ltd.
Not ingested
K250041
Medical Picosecond ND: YAG Laser System (PZ-6)
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Not ingested

3 submissions cite Ami, Inc. as a predicate