Realton (Suzhou) Medical Technology Co., Ltd.

Country / region:China (CN)

510(k) submissions

Latest clearance

2021-06-04

Product codes

GEX

Cited as predicate

Product areas

FDA product code distribution

3 total

K number	Device name	Product code	Class	Decision date
K202828	Surgical Green Laser System	GEX	Class 2	2021-06-04
K202702	FLARE Single-Use Surgical Laser Fiber	GEX	Class 2	2021-02-26
K202601	Single-use Sterile medical laser fiber	GEX	Class 2	2020-12-15

K092735
—
—
Not ingested
K202601
—
—
Not ingested
K170121
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
Lumenis, Ltd.
K120870
—
—
Not ingested

Realton (Suzhou) Medical Technology Co., Ltd. references 4 predicate/reference devices

2 submissions cite Realton (Suzhou) Medical Technology Co., Ltd. as a predicate