# K193486: Epic 980

- Pathway: 510(k) (Traditional)
- Applicant: Biolase, Inc.
- Decided: Mar 16, 2020 after 90 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: 19 generations back to K943450 (1995). 239 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 242 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192430: Epic 980, Biolase, Inc. (2019) Summary page 5.
- K100474: Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W, Quicklase Limited (2010) Summary page 5.
- K103753: Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser, Sirona Dental Systems GmbH (2011) Summary page 5.
- K152032: ELUMI 810 + 980 Soft Tissue Laser, Azena Medical, LLC (2015) Summary page 5.

## Most influential descendants
- K234085: LUNE™ PureHygiene (2024), 1 descendant of its own
- K260138: LUNE PureHygiene (2026), 0 descendants of its own

## Indications for use
Dental Soft Tissue Indications Incision, excision, vaporization, ablation and coagulation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: • Excisional and incisional biopsies • Exposure of unerupted teeth • Fibroma removal • Frenectomy • Frenotomy • Gingival troughing for crown impressions • Gingivectomy • Gingivoplasty • Gingival incision and excision • Hemostasis 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 • Soft-tissue crown lengthening • Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa • Vestibuloplasty • Tissue retraction for impression • Laser soft-tissue curettage • Laser removal of diseased, infected, inflamed and necrosed soft-tissue within the periodontal pocket • Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) • Reduction of bacterial level (decontamination) and inflammation • Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium • Lesion (tumor) removal • Removal of hyperplastic tissues • Laser assisted flap surgery • Removal of granulation tissue Whitening • Light activation for bleaching materials for teeth whitening • Laser-assisted whitening/bleaching of teeth Pain Therapy • Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Source page: https://510kreport.com/device/K193486
Methodology: https://510kreport.com/methodology