# K220531: Fox 810, Fox 980

- Pathway: 510(k) (Traditional)
- Applicant: A.R.C Laser GmbH
- Decided: Sep 1, 2022 after 189 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). 636 ancestors in all.
No later device cites it as a predicate yet.
0 of 637 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 4.
- K202991: Fotona XPulse Pro Laser Platform, Fotona D.O.O. (2021) Summary page 4.

## Indications for use
FOX 810: 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, neurosurgery, otolaryngology, and pulmonology. FOX 980: 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, pulmonology, and thoracic surgery.

Source page: https://510kreport.com/device/K220531
Methodology: https://510kreport.com/methodology