A.R.C. Laser Surgical Fibers and Probes

A.R.C Laser GmbH

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

View Summary PDF

Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K161403
Device name
A.R.C. Laser Surgical Fibers and Probes
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-05-20
Decision date
2016-08-16
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The A.R.C laser surgery fibers and probes are intended for delivery of laser energy to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue.

The A.R.C laser surgery fibers and probes are indicated for use in General Surgery, Urology, Gynecology and ENT with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.

Intended Use

The A.R.C laser surgery fibers and probes are intended for delivery of laser energy to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. The A.R.C laser surgery fibers and probes are indicated for use in General Surgery, Urology, Gynecology and ENT with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.

Device Description

The A.R.C. surgical laser fibers & probes are single use laser delivery devices provided EO sterile and intended for medical applications in various fields of laser surgery. The devices are based on a quartz core, have a length of 6.5 feet (2 meters) to 9.9 feet (3 meters) and a wavelength range between 450nm to 2100nm. The proximal end of the fibers is connected to a cleared laser system via an SMA 905 connector, while the distal end delivers the laser energy to the target tissue in pulsed and continuous wave mode. The distal end has a bare tip which may be flat or spherical, and may be used with a variety of sterile hand pieces for the various intended uses and effects.

Summary parsed at:2026-06-01 06:06:25 UTC

Predicate devices

1

K161403 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K161403 as a predicate