# K113212: Dental Laser Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: China Daheng Group, Inc.
- Decided: Nov 16, 2011 after 15 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: 8 generations back to K922901 (1992). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081214: Styla Microlaser and Stylaortho, Zap Lasers, LLC (2008) Summary page 2.
- K093852: Ezlase 3 Laser System, Biolase Technology, Inc. (2010) Summary page 2.

## Most influential descendants
- K123004: Mira Lasers (2013), 0 descendants of its own

## Indications for use
The PenLase is indicated for incision, excision, hemostasis, coagulation and vaporization of soft tissue including the following indications: * Excision and Incision Biopsies * Hemostatic assistance * Treatment of Apthous Ulcers * Frenectomy * Frenotomy * Gingival Incision and Excision * Gingivectomy * Gingivoplasty * Incising and Draining of Abscesses * Operculectomy * Oral Papillectomy * Removal of Fibromas * Soft Tissue Crown Lengthening * Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) * Tissue retraction for Impression * Vestibuloplasty

Source page: https://510kreport.com/device/K113212
Methodology: https://510kreport.com/methodology