# K100143: Pilot Diode Laser, Model 002-00139

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Aug 13, 2010 after 206 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: 15 generations back to K943450 (1995). 185 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 206 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063396: Velure Family of Diode Lasers and Delivery Device Accessories, Lasering S.R.L. (2007) Summary page 1.
- K062619: Denlaser 800 Plus, CAO Group, Inc. (2006) Summary page 1.
- K070024: Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode Probe, Thor International (2007) Summary page 1.

## Most influential descendants
- K123443: Precise SHP Diode Laser (2013), 9 descendants of its own
- K122567: Joule 810/940/980 Multi-Platform System (2013), 6 descendants of its own
- K162114: Photon, Photon Plus (2016), 3 descendants of its own
- K151890: Medical Diode Laser Systems (2015), 3 descendants of its own
- K200693: K2 Mobile (2020), 2 descendants of its own

## Indications for use
The Pilot Diode Laser is indicated for the procedures of 1) Removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue in the medical fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, general surgery, urology, gynecology, and plastic surgery. And 2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.

Source page: https://510kreport.com/device/K100143
Methodology: https://510kreport.com/methodology