# K161403: A.R.C. Laser Surgical Fibers and Probes

- Pathway: 510(k) (Traditional)
- Applicant: A.R.C Laser GmbH
- Decided: Aug 16, 2016 after 88 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K943450 (1995). 402 ancestors in all.
No later device cites it as a predicate yet.
0 of 403 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152417: Adler MicroMed Laser Surgery Fibers, Adler Micromed, Inc. (2015) Summary page 4.

## 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.

Source page: https://510kreport.com/device/K161403
Methodology: https://510kreport.com/methodology