Wuhan Gigaa Optronics Technology Co., Ltd.

Country / region:China (CN)

510(k) submissions

Latest clearance

2017-04-07

Product codes

GEX

Cited as predicate

Product areas

FDA product code distribution

2 total

K number	Device name	Product code	Class	Decision date
K160549	MEDICAL DIODE LASER SYSTEMS	GEX	Class 2	2017-04-07
K151890	Medical Diode Laser Systems	GEX	Class 2	2015-12-23

Wuhan Gigaa Optronics Technology Co., Ltd. references 5 predicate/reference devices

K252063
Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)
Wuhan Dimed Laser Technology Co., Ltd.
K241930
Veincare
Wontech Co., Ltd.
K234004
Medical diode laser systems (CHARISMA, REGAL)
Reveal Lasers , Ltd.
K211977
Medical Diode Laser Systems
Wuhan Dimed Laser Technology Co., Ltd.
Not ingested
K191349
980nm Diode Laser Therapy Device
Shanghai Apolo Medical Technology Co., Ltd.
K173067
LightForce LTS Model 1000, 1500, 2500, and 4000
Litecure, LLC
Not ingested

6 submissions cite Wuhan Gigaa Optronics Technology Co., Ltd. as a predicate