# K100474: Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W

- Pathway: 510(k) (Traditional)
- Applicant: Quicklase Limited
- Decided: Mar 16, 2010 after 26 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). 24 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072995: Twinwave Dental Laser, Tidalwave 810 Dental Laser, Tidalwave 980 Dental Laser, Lumen Development and Manufacturing, Inc. (2007). Our reading of the summary gave K072295, FDA’s number for Capnostream 20 with A2 Adaptive Averaging Software (Oridion Capnography, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “TwinWave and TidalWave”. Summary page 3.
- K063384: Diodent Micro Dental Laser System, Models 810 and 980, Hoya Conbio, Inc. (2007) Summary page 2.
- K062258: Genesis Diode Laser, Ivoclar Vivadent, Inc. (2007)
- K053161: Sirolaser, Sirona Dental Systems GmbH (2006) Summary page 2.
- K030539: Lasersmile, Biolase Technology, Inc. (2003) Summary page 2.

## Most influential descendants
- 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
- K210350: Gemini 2 810+980 Soft Tissue Laser (2021), 1 descendant of its own

## Indications for use
For the incision, excision, ablation, vaporization, hemnostasis, and treatment of oral soft tissue. Examples: Excisional and incisional biopsies Frenectomy and Frenotomy Exposure of unerupted teeth Gingval Troughing for crown impressions Fibroma removal Gingivectomy Gingivoplasty Ginigival incision and excision Hemnostasis and coagulation 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 Treatment of apthous ulcers Vestibuloplasty Lesion (tumor) removal Laser Soft Tissue Curettage Treatment of canker sores, herpetic and other ulcers of the oral mucosa Tissue Retraction Removal of Diseased, Infected, Inflamed and necrotic soft tissue within the periodontal pocket Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithliumn Sulcular debridement (removal of necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices ingluding gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility Light activation of bleaching materials for teeth whitening Laser-assisted whitening/bleaching of teeth

Source page: https://510kreport.com/device/K100474
Methodology: https://510kreport.com/methodology