# K063384: Diodent Micro Dental Laser System, Models 810 and 980

- Pathway: 510(k) (Traditional)
- Applicant: Hoya Conbio, Inc.
- Decided: Mar 16, 2007 after 128 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: 5 generations back to K922901 (1992). 15 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053161: Sirolaser, Sirona Dental Systems GmbH (2006) Summary page 1.
- K050274: Diodent II Dental Laser System, Hoya Photonics, Inc. (2005) Summary page 1.
- K991994: Twilight, Biolase Technology, Inc. (1999) Summary page 1.

## Most influential descendants
- K100474: Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W (2010), 8 descendants of its own
- K152032: ELUMI 810 + 980 Soft Tissue Laser (2015), 7 descendants of its own
- K193486: Epic 980 (2020), 2 descendants of its own
- K192617: Gemini 810+980 Soft Tissue Laser (2020), 2 descendants of its own
- K234085: LUNE™ PureHygiene (2024), 1 descendant of its own

## Indications for use
For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue. Examples: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Reduction of bacterial level (decontamination) and inflammation Soft tissue crown lengthening Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Treatment of aphthous ulcers Vestibuloplasty Biopsy incision and excision Lesion (tumor) removal For light activation for bleaching materials for teeth whitening For laser-assisted bleaching/whitening for teeth.

Source page: https://510kreport.com/device/K063384
Methodology: https://510kreport.com/methodology