# K062619: Denlaser 800 Plus

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Nov 14, 2006 after 70 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: 3 generations back to K011041 (2001). 7 ancestors in all.
40 later devices descend from it; 5 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050, Ivoclar Vivadent, Inc. (2005) Summary page 1.
- K032864: Ceralas D 810 Diode Laser System, Model D15, Biolitec, Inc. (2004) Summary page 1.
- K993285: Aurora SL, Premier Laser Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K073322: Fox 1-980, Fox Q-1064, Fox-Q-810 (2008), 22 descendants of its own
- K100143: Pilot Diode Laser, Model 002-00139 (2010), 20 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K113472: Precise SHP Diode Laser (2012), 10 descendants of its own
- K123443: Precise SHP Diode Laser (2013), 9 descendants of its own

## Indications for use
The DenLaser 800 Plus 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, gynecology, and plastic surgery.

Source page: https://510kreport.com/device/K062619
Methodology: https://510kreport.com/methodology