G.N.S Neolaser , Ltd.

Country / region:Israel (IL)

510(k) submissions

2

Latest clearance

2025-03-13

Product codes

1

GEX

Cited as predicate

5

Product areas

FDA product code distribution

510(k) submissions

2 total

K number	Device name	Product code	Class	Decision date
K250113	neoLaser Laser Surgery Fibers	GEX	Class 2	2025-03-13
K152722	neoV980 & neoV1470 Diode Lasers	GEX	Class 2	2015-12-08

Company profile

Canonical name: G.N.S Neolaser , Ltd.
Country: Israel(IL)

Cited predicates

5

K232769
BeaMed Laser Surgery Fibers
Bt Beamedical Tachnoogies Ltd. (Beamed)
K100558
—
—
Not ingested
K112253
—
—
Not ingested
K112324
—
—
Not ingested
K133006
—
—
Not ingested

G.N.S Neolaser , Ltd. references 5 predicate/reference devices

Cited as predicate

5

K251049
SurgiLight 1470 Diode Laser System (Model:Halo)
Micro-Energy Medical Technology Co., Ltd.
K240747
Medical Diode Laser (M2-GK)
Wuhan Pioon Technology Co., Ltd.
K240644
Medical Diode Laser (S1Pro)
Wuhan Pioon Technology Co., Ltd.
K233344
Regenalase Laser System
Ipg Medical
K193656
SkyPulse
Fotona D.O.O.

5 submissions cite G.N.S Neolaser , Ltd. as a predicate