Shangdong Huamei Technology Co., Ltd.

Country / region:China (CN)

510(k) submissions

3

Latest clearance

2020-11-16

Product codes

1

GEX

Cited as predicate

7

Product areas

FDA product code distribution

510(k) submissions

3 total

K number	Device name	Product code	Class	Decision date
K202758	Nd: YAG Laser Therapy Systems HM-YL900	GEX	Class 2	2020-11-16
K200751	Photodynamic Therapy (PDT) Equipment	GEX	Class 2	2020-05-21
K192528	CO2 Laser Therapy System	GEX	Class 2	2019-12-03

Company profile

Canonical name: Shangdong Huamei Technology Co., Ltd.
Country: China(CN)

Cited predicates

5

K113588
—
—
Not ingested
K122922
—
—
Not ingested
K190936
Q-Switched Nd: YAG Laser System
Shanghai Apolo Medical Technology Co., Ltd.
K190938
Phototherapy System
Shanghai Apolo Medical Technology Co., Ltd.
K161925
CO2 Laser Therapy Machine
Beijing Adss Development Co., Ltd.

Shangdong Huamei Technology Co., Ltd. references 5 predicate/reference devices

Cited as predicate

7

K260375
Nd: YAG Laser Therapy Systems
Sanhe Meditech Co., Ltd.
K252515
Q-Switched Nd:Yag laser (K690)
Hebei Keylaser Sci-Tech Co.,Ltd
K232532
Nd:Yag Laser Therapy Systems
Beijing Unt Technology Co., Ltd.
K230342
Phototherapy System (OL-PDT950)
Shanghai Omni Laser Skinology Co., Ltd.
K212611
CO2 Laser Equipment
Beijing Globalipl Development Co., Ltd.
K202250
Dermatological Carbon Dioxide Laser Systems
Zhuolu Jontelaser Manufacturing Technology Co., Ltd.
K200042
CO2 Laser System
Beijing Superlaser Technology Co., Ltd.

7 submissions cite Shangdong Huamei Technology Co., Ltd. as a predicate