Lumenis Be, Ltd.

Country / region:Israel (IL)

510(k) submissions

Latest clearance

2025-04-16

Product codes

GEX

Cited as predicate

Product areas

FDA product code distribution

4 total

K number	Device name	Product code	Class	Decision date
K250809	Stellar M22	GEX	Class 2	2025-04-16
K242349	FoLix	GEX	Class 2	2024-09-09
K233301	ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories	GEX	Class 2	2023-12-01
K220467	The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories	GEX	Class 2	2022-05-18

K193500
Stellar M22 for Intense Pulsed Light (IPL) and Laser System
Lumenis, Ltd.
K222790
—
—
Not ingested
K022060
—
—
Not ingested
K030147
—
—
Not ingested
K203544
UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
Lumenis, Ltd.

Lumenis Be, Ltd. references 5 predicate/reference devices

No later 510(k)s cite this device yet

Other submissions will appear here when they list Lumenis Be, Ltd. as a predicate