neoLaser Laser Surgery Fibers

G.N.S Neolaser , Ltd.

Country / region:Israel (IL)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Israel (IL)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K250113
Device name
neoLaser Laser Surgery Fibers
Country / region
Israel(IL)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-01-16
Decision date
2025-03-13
Submission type
Traditional
Technology type
Laser fiber / delivery(AI inferred)
Clinical applications
Surgical cuttingVascular treatmentOtherSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. The neoLaser Laser Surgery Fibers are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.

Intended Use

The Fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.

Device Description

The neoLaser Laser Surgery Fibers are sterile, single use, laser delivery devices intended for medical applications in various fields of laser surgery. They are intended to deliver energy to soft tissue in contact and non-contact mode during various surgical applications, including via endoscopes and cytoscopes. The fibers are designed to transmit energy from the laser system to the treatment site, as well as to transmit a low power laser aiming beam to assist in the visibility of the target tissue.

Summary parsed at:2026-06-01 05:22:06 UTC

Predicate devices

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