# K142223: Pilot Pro Diode Laser

- Pathway: 510(k) (Special)
- Applicant: CAO Group, Inc.
- Decided: Sep 12, 2014 after 30 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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 4.

## Indications for use
The Pilot Pro Diode Laser is indicated for the procedures of removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue in the fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, plastic surgery, urology, and gynecology.

Source page: https://510kreport.com/device/K142223
Methodology: https://510kreport.com/methodology