# K181602: Pioneer Elite Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Sep 10, 2019 after 448 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: 18 generations back to K943450 (1995). 207 ancestors in all.
No later device cites it as a predicate yet.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131059: Pioneer Elite Diode Laser, CAO Group, Inc. (2013) Summary page 4.

## Indications for use
The Pioneer Elite Diode Laser is indicated for dentistry and oral soft tissue procedures of: 1) The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed ededematous tissue. 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; 3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

Source page: https://510kreport.com/device/K181602
Methodology: https://510kreport.com/methodology