# K091059: Foxq 980 Laser

- Pathway: 510(k) (Traditional)
- Applicant: A.R.C Laser GmbH
- Decided: Aug 13, 2009 after 121 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: 17 generations back to K943450 (1995). 388 ancestors in all.
No later device cites it as a predicate yet.
0 of 389 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073322: Fox 1-980, Fox Q-1064, Fox-Q-810, A.R.C Laser GmbH (2008) Summary page 1.
- K082721: Laserpro 810, 940 and 980 Diode Laser Systems, Photo Medex, Inc. (2008) Summary page 1.

## Indications for use
The Fox Q-980 Diode Laser is indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, thoracic surgery and laser assisted lipolysis.

Source page: https://510kreport.com/device/K091059
Methodology: https://510kreport.com/methodology