# K071896: Fox 940, Model 940

- Pathway: 510(k) (Traditional)
- Applicant: Valam, Inc.
- Decided: Feb 22, 2008 after 228 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: 4 generations back to K011041 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062619: Denlaser 800 Plus, CAO Group, Inc. (2006) Summary page 1.
- K040294: Laserpro Diode Laser Systems, Models 810, 940 & 980, Photo Medex, Inc. (2004). Our reading of the summary gave K040924, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “LaserPro”.

## Indications for use
The Fox 940 Diode Laser is indicated for: Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery

Source page: https://510kreport.com/device/K071896
Methodology: https://510kreport.com/methodology