# K102669: Diode Laser Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: China Daheng Group, Inc.
- Decided: Nov 17, 2010 after 62 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: 6 generations back to K922901 (1992). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062258: Genesis Diode Laser, Ivoclar Vivadent, Inc. (2007) Summary page 2.
- K072262: Gentleray 980 Diode Laser System, Kavo America (2007) Summary page 2.
- K083142: Picasso Laser System, Amd Lasers, LLC (2009) Summary page 2.
- K053161: Sirolaser, Sirona Dental Systems GmbH (2006) Summary page 2.

## Most influential descendants
- K131839: DC 7 (2013), 0 descendants of its own

## Indications for use
The Diode Laser Therapy System (DenLase-81 017 & DenLase-98017) is indicated far intraoral use for the following soft tissue applications: * Incision * Excision * Vaporization * Ablation * Coagulation.

Source page: https://510kreport.com/device/K102669
Methodology: https://510kreport.com/methodology