Jeisys Medical Incorporated

Country / region:Korea, Republic of (KR)

510(k) submissions

Latest clearance

2025-10-03

Product codes

GEX

Cited as predicate

Product areas

FDA product code distribution

4 total

K number	Device name	Product code	Class	Decision date
K251464	TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)	GEX	Class 2	2025-10-03
K223685	SmoothCool HR System	GEX	Class 2	2023-01-04
K213484	SmoothCool HR System	GEX	Class 2	2022-04-20
K162169	EdgeOne CO2 Laser	GEX	Class 2	2016-10-27

K241527
Pastelle Pro
Wontech Co., Ltd.
K213484
—
—
Not ingested
K082911
—
—
Not ingested
K193500
Stellar M22 for Intense Pulsed Light (IPL) and Laser System
Lumenis, Ltd.
K100590
—
—
Not ingested
K133895
—
—
Not ingested

Jeisys Medical Incorporated references 6 predicate/reference devices

K250998
CO2 Laser Therapy System (Model: LFS-D9U)
Sanhe Lefis Electronics Co., Ltd.
Not ingested
K250465
CO2 Laser Machine (Lume)
Nanjing Bestview Laser S&T Co., Ltd.
Not ingested
K232133
Co2 Laser System, Models: PureLase And VanLase
Cpmt Laser (Canadian Pioneer Medical Technology Corporation)
Not ingested
K223685
SmoothCool HR System
Jeisys Medical, Inc.
Not ingested
K201109
CO2 Laser Therapy System
Shanghai Apolo Medical Technology Co., Ltd.
Not ingested
K191518
CO2 Laser System
Shenzhen Gsd Tech Co., Ltd.
Not ingested

6 submissions cite Jeisys Medical Incorporated as a predicate